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Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 10  |  Issue : 2  |  Page : 201-206  

Comparative clinical study of gabapentin and pregabalin for postoperative analgesia in laparoscopic cholecystectomy


1 Department of Anesthesia and Critical Care, AIIMS, New Delhi, India
2 Department of Anesthesia and Critical Care, Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh, India
3 Department of Anesthesia and Critical Care, M. L. N. Medical College, Allahabad, Uttar Pradesh, India

Date of Web Publication26-Apr-2016

Correspondence Address:
Manoj Tripathi
2/126 A, Vikrant Khand, Gomti Nagar, Lucknow - 226 010, Uttar Pradesh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0259-1162.176409

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   Abstract 


Background: Reduction in central sensitization by gabapentinoids that include gabapentin and pregabalin may reduce acute postoperative pain.
Aims: The aim of this study is to evaluate postoperative analgesic benefit and efficacy in patients administered with oral gabapentin or pregabalin as premedication for laparoscopic cholecystectomy under general anesthesia.
Settings and Design: Randomized, prospective, and comparative study.
Materials and Methods: In this study, recruited patients were randomly allocated in three groups. Groups A, B, and C received 2 capsules of B complex, 3 capsules of 300 mg gabapentin each, and 2 capsules of 75 mg pregabalin, respectively, each in 30 patients of each group, 1 h before induction of anesthesia. Postoperative efficacy among these three groups was compared with respect to increase in duration of analgesia, reduction in postoperative pain scores, total postoperative requirements of analgesics and side effects.
Statistical Analysis: Mean and standard deviation were calculated. Test of analysis between two groups was done by t-test and among three groups by analysis of variance, and then P value was calculated.
Results: Pregabalin and gabapentin group had lower visual analog scale (VAS) score (P < 0.05), prolonged timing of first rescue analgesic (4.67 ± 14.79 vs. 158 ± 13.10 vs. 343.16 ± 9.69) min, and less opioid consumption (169.87 ± 20.32 vs. 116.13 ± 14.08 vs. 64.67 ± 16.69) mg compared to placebo group. Between the gabapentinoids, pregabalin group had lower VAS score, prolonged timing of first rescue analgesic, and less opioids consumption than the gabapentin group.
Conclusion: It is concluded in this study that pregabalin group had lower VAS score, prolonged timing of first rescue analgesic, and less opioids consumption than the gabapentin group. Both gabapentinoids had better postoperative analgesic profile than placebo.

Keywords: Gabapentin, laparoscopic cholecystectomy, postoperative analgesia, pregabalin, Ramsay sedation score, visual analog scale


How to cite this article:
Mishra R, Tripathi M, Chandola H C. Comparative clinical study of gabapentin and pregabalin for postoperative analgesia in laparoscopic cholecystectomy. Anesth Essays Res 2016;10:201-6

How to cite this URL:
Mishra R, Tripathi M, Chandola H C. Comparative clinical study of gabapentin and pregabalin for postoperative analgesia in laparoscopic cholecystectomy. Anesth Essays Res [serial online] 2016 [cited 2019 Nov 14];10:201-6. Available from: http://www.aeronline.org/text.asp?2016/10/2/201/176409




   Introduction Top


There has been a rapid growth in the interest of anesthesiologists in the management of acute pain and postoperative pain [1] over the past few decades. Traditionally, opioids have been the mainstay of management of moderate to severe pain of postoperative patients. However, opioid analgesics are not devoid of their share of side effects. Gabapentinoids have antiallodynic and antihyperalgesic properties with only a minor effect on normal nociception. Reduction in central sensitization by an antihyperalgesic drug like gabapentinoid may reduce acute postoperative pain.

In a more recent systematic review [2] with focus on procedure-specific effects of gabapentin in postoperative pain, demonstrated that preoperative gabapentin reduces 24-h postoperative opioid consumption for patients in abdominal hysterectomy and spinal surgery. Pregabalin is a structural analog of gamma amino butyric acid, which shares some characteristics with its predecessor, gabapentin. Its mechanism of action is probably the same as gabapentin but it has a superior pharmacokinetic profile.[3] Its usefulness has already been established in the treatment of peripheral neuropathic pain [4],[5],[6] It is claimed to be more effective in preventing neuropathic component of acute nociceptive pain of surgery, to produce more opioid-sparing effect and for the amelioration of perioperative anxiety. The efficacy of pregabalin for treating symptoms of generalized anxiety disorder has been demonstrated in several clinical trials.[7],[8]

The aim of this study is to evaluate postoperative analgesic benefit in patients administered with oral gabapentin or pregabalin as premedication for laparoscopic cholecystectomy under general anesthesia and to compare their postoperative efficacy with respect to increase in duration of analgesia, reduction in postoperative pain scores, total postoperative requirements of analgesics, study side effects and complications, if any attributable to these drugs.


   Materials and Methods Top


This study titled “Comparative clinical study of gabapentin and pregabalin for postoperative analgesia in laparoscopic cholecystectomy” was carried out in surgical patients scheduled for laparoscopic cholecystectomy, admitted to S. R. N. Hospital of M. L. N. Medical College, Allahabad, for 1-year period. Before the beginning of the study, proper approval was taken from the Research Ethical Committee. The study included 90 patients with American Society of Anesthesiologists status I and II of either sex in the age group of 20–60 years, weighing 40–70 kg, scheduled for elective laparoscopic cholecystectomy.

Patients with the following conditions were excluded from the study: known history of hypersensitivity to drugs to be used, history of drug or alcohol abuse, uncontrolled concomitant medical diseases (hypertension, bronchial asthma, diabetes mellitus), patients with history of chronic pain conditions, impaired kidney or liver function, daily intake of analgesics or corticosteroids and intake of nonsteroidal anti-inflammatory drugs or paracetamol 24 h before operation, laparoscopic cholecystectomy converted into open cholecystectomy, and patients on anticoagulant therapy or antidepressants and obesity.

The selected patients were randomly allocated to one of the following three groups irrespective of age or gender. Randomization was achieved by using random number tables.

Group A: Placebo, 30 patients who received oral Vitamin B complex in the form of 2 capsules 1 h prior to the induction of anesthesia.

Group B: Gabapentin - 30 patients who received 900 mg oral gabapentin in the form of 3 capsules containing 300 mg of gabapentin about 1 h prior to the induction of anesthesia.

Group C: Pregabalin - 30 patients who received 150 mg oral pregabalin in the form of 2 capsules containing 75 mg pregabalin about 1 h prior to the induction of anesthesia.

Patients were visited in their respective wards on the day before the surgery for preanesthetic check-up. A thorough history was taken, general and systemic examination was performed, and their laboratory data were reviewed. Before proceeding for the study, written and informed consent was taken from the patients scheduled for surgery, individually or from their guardians. Each patient was premedicated with tablet alprazolam (0.25 mg) and tablet ranitidine (150 mg) on the night before the surgery. On the morning of the surgery, patients were visited in the preoperative ward about 1 h before the induction of anesthesia and depending on their position in the random number tables, they were given one of the three oral drugs (placebo or gabapentin or pregabalin) with sip of water. Afterward they were transferred to the operation theater.

On arrival to the operation theater table, an intravenous (i.v.) infusion line was secured to the patients. Monitors were connected and baseline recordings of pulse, systolic blood pressure, diastolic blood pressure, respiratory rate, (pulse oximetry) SpO2, and electrocardiography (ECG) tracings were taken. All the patients received similar premedication consisting of injection glycopyrolate (0.004 mg/kg), injection ondansetron (4 mg) and injection fentanyl (2 µg/kg) for intraoperative analgesia that was given intravenously approximately 3 min prior to endotracheal intubation. General anesthesia was induced with injection propofol (1.5–2.5 mg/kg) after preoxygenation for 3 min injection vecuronium bromide (0.1 mg/kg) was used to facilitate endotracheal intubation. Intraoperative monitoring consisted of ECG, noninvasive blood pressure (NIBP), SpO2, pulse rate and end-tidal CO2 (ETCO2). Anesthesia was maintained using 50% O2 + 50% air, injection vecuronium and isoflurane that were titrated according to blood pressure (BP). Injection fentanyl was used in a bolus of 50 µg for the management of pain intraoperatively. Ventilation was adjusted to maintain ETCO2 within range of 30–40 mmHg. After the completion of surgery, the residual neuromuscular blockade was antagonized using injection neostigmine (0.05 mg/kg) and injection glycopyrrolate (0.01 mg/kg). After pharyngeal suctioning and adequate recovery of spontaneous ventilation, patients were extubated. Subsequently, patients were shifted to the recovery room. On arrival to the recovery room, the pulse rate, NIBP, respiratory rate, pain scores (on visual analog scale [VAS]), and sedation score (Ramsay sedation score) were recorded and the time was designated as T0, After stabilization of the patients, they were sent to the respective wards. In the wards, the pain and sedation scores of the patients were continuously recorded at 1st h, 2nd h, 3rd h, 6th h, 9th h, 12th h, 18th h, and 24th h and the times were designated as T1, T2, T3, T6, T9, T12, T18, and T24, respectively. In addition to this, pulse, BP and respiratory rates were also recorded. Whenever the pain score of a particular patient was ≥4, the patient was given injection tramadol (1 mg/kg) i.v. as a rescue analgesic. The total amount of tramadol consumed by the patients in each group was also recorded.

Postoperatively, patients were also observed for the occurrence of sedation, nausea, vomiting, and other side effects such as respiratory depression, headache, dizziness, visual disturbances, and somnolence were also recorded. Patients having sedation score of ≥2 were considered sedated, and patient's whose respiratory rate was <8/min were considered in respiratory depression. Patients were asked to rate their nausea on a four-point scale of none, mild, moderate, and severe. Intravenous ondansetron (4 mg i.v.) was given if the patients had moderate or severe nausea or an episode of vomiting.

Statistical analysis

Data obtained from the patients under study were recorded in a standard Performa. The parametric data were expressed as mean ± standard deviation. Test for analysis among three groups was done by analysis of variance (ANOVA) for quantitative and Chi-square test for qualitative data. Comparison between two groups was done by t-test. A P value of <0.05 was considered statistically significant and a P > 0.05 was not considered statistically significant.


   Observations and Results Top


No significant statistical difference was found among the study groups in respect of age, sex, weight, duration of surgery, and baseline laboratory investigations such as pulse rate, mean arterial pressure, and respiratory rate as shown in [Table 1]. The amount of fentanyl used for intraoperative analgesia was statistically insignificant among the three groups (P = 0.372). As shown in [Table 2], pregabalin and gabapentin group had lower VAS score compared to placebo (P < 0.05). [Table 3] shows pregabalin and gabapentin group had prolonged timing of first rescue analgesic compared to placebo group (4.67 ± 14.79, 158 ± 13.10, 343.16 ± 9.69) min and pregabalin and gabapentin groups consumed significantly less opioids in comparison to placebo group (169.87 ± 20.32, 116.13 ± 14.08, 64.67 ± 16.69) mg. Between the gabapentinoids, pregabalin group had lower VAS score [Table 2], prolonged timing of first rescue analgesic and less opioids consumption than the gabapentin group [Table 3]. Pregabalin and gabapentin provided better analgesia than the placebo but among them, postoperative analgesia was significantly better provided by pregabalin compared to gabapentin. As shown in [Table 4], the side effects seen in this study were sedation, nausea, vomiting, respiratory depression and vertigo. [Table 5] shows postoperative sedation was significantly more in the pregabalin group till 3 h postoperatively compared to the gabapentin and placebo groups, whereas the other side effects were comparable in all the three groups (P > 0.05). Even though the pregabalin group had sedation as more pronounced side effect in this study, but it may be beneficial with regard to preoperative anxiety and intraoperative anesthetic drug dosage reduction.
Table 1: Demographic data

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Table 2: Postoperative visual analogue scale score of different groups

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Table 3: Timing of first rescue analgesic and tramadol consumption

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Table 4: Complications in different groups postoperatively

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Table 5: Postoperative sedation score in different groups

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   Discussion Top


Experimental models of neuropathic pain and inflammatory hyperalgesia have shown that γ-amino butyric acid analogs such as gabapentin and pregabalin have antinociceptive and antihyperalgesic properties.[9],[10]

In this study, postoperative pain was assessed by VAS score which was explained to the patient preoperatively. Assessment of VAS was done in 1st h, 2nd h, 3rd h, 6th h, 9th h, 12th h, 18th h, and 24th h postoperatively. VAS score was significantly reduced in pregabalin group compared to gabapentin and placebo groups in the immediate and late postoperative period (P < 0.001) [Table 2]. Similarly, Pandey et al.[11] in a randomized, placebo-controlled trial of gabapentin versus tramadol in laparoscopic cholecystectomy found lower pain scores at all time intervals postoperatively in gabapentin group in comparison to tramadol and placebo group. In their study, there was continuous reduction in VAS score in the gabapentin group over 24 h, while in this study two peaks were seen due to increase in VAS, the most probable reason might be wider time interval used for VAS assessment in the previous group. Agarwal et al.[12] while evaluating the efficacy of a single preoperative dose of pregabalin for attenuating postoperative pain and opioid consumption found that both static (at rest) and dynamic (on coughing) VAS score was significantly lower in the pregabalin group compared to the placebo. Few studies reveal contradictory results compared to the present study. One study conducted by Bartholdy et al.[13] revealed that oral gabapentin 1200 mg given preoperatively in laparoscopic sterilization using Filshie clips had no significant reduction in pain score as compared to placebo. It can be explained by these reasonings— firstly gabapentin was given 30 min prior to surgery while it reaches peak plasma concentration within 2–3 h and secondly higher dose of gabapentin was used and studies had shown that bioavailability of gabapentin decreases with increase in dose. In a randomized placebo-controlled trial of oral pregabalin for postoperative pain relief after minor gynecological surgery, Paech et al.[14] reported that a single preoperative dose of 100 mg pregabalin was ineffective in reducing acute postoperative pain or improving recovery after minor surgery involving only the uterus. The difference in results from our study could possibly be because they had administered a smaller dose (100 mg) against the recommended starting dose of 150 mg.

Sedation score was analyzed in this study in the postoperative period, whenever the patient's Ramsay sedation score was ≥2, it was considered sedated. So in this study, it was noted that the sedation score was significantly more in pregabalin compared to the gabapentin and placebo group at T0 and T3 but the sedation score was never more than 4 [Table 5]. By seeing the level of sedation score its severity can be predicted. Although just after recovery from anesthesia sedation score in pregabalin group (1.9 ± 1.08) was significantly higher as compared to gabapentin group (1.53 ± 0.73) and placebo group (1.2 ± 0.5), there was no significant difference in pregabalin and gabapentin group. Turan et al.[15] while investigating the efficacy and safety of gabapentin in rhinoplasty or endoscopic sinus surgery revealed that sedation score was similar in both gabapentin and placebo group. However, Pandey et al.[11] in their study on laparoscopic cholecystectomy reported a higher incidence of sedation (33.98% is 3.3% P < 0.05) in the gabapentin-treated group as compared to the placebo group. This difference in the levels of sedation in the above two studies may be attributed to the different sample size between the studies. White et al.[16] concluded in his study that preoperative pregabalin administration (oral 75–300 mg) increased perioperative sedation in a dose-related fashion. On comparing the above study and present study, it is revealed that severity of sedation was seen more in their study when they used pregabalin 300 mg but in the present study the sedation scores were moderate because of moderate dose of pregabalin 150 mg.

The timing of first rescue analgesic postoperatively in this study was significantly more in pregabalin group (343.16 ± 9.69 min) compared to gabapentin (158 ± 13.10 min) and placebo (4.67 ± 14.79 min) groups [Table 3], whereas timing of first rescue analgesic in gabapentin group was significantly more than that of placebo group. Possibly no previous study of gabapentin and pregabalin had analyzed and compared the timing of first rescue analgesic postoperatively in surgery under general anesthesia. However, a study was conducted by Saraswat and Arora [17] comparing the analgesic efficacy of gabapentin and pregabalin in surgery under spinal anesthesia. They concluded that similar to this study, it was seen that the total postoperative analgesic time was significantly more in pregabalin (14.17 h) as compared to gabapentin (8.98 h) group.

It was found that the pregabalin (64.67 ± 16.69 mg) group consumed significantly less tramadol as compared to the gabapentin (116.13 ± 14.08 mg) and placebo (169.87 ± 20.32 mg) group and the difference between gabapentin and placebo group was also statistically significant (P < 0.001) [Table 3]. Pandey et al.[11] in their study on gabapentin role as postoperative analgesia in laparoscopic cholecystectomy demonstrated that the total fentanyl consumption (221.16 ± 52.39 µg) postoperatively was significantly less in gabapentin group than in the tramadol group (269.60 ± 44.17 µg) and placebo group (355.86 ± 42.04 µg). While Agarwal et al.[12] in their study to evaluate role of pregabalin in attenuating postoperative pain and total fentanyl consumption found that the total postoperative patient-controlled fentanyl consumption was significantly reduced in pregabalin group (555.2 ± 124.8 µg) compared to placebo group (757.5 ± 99.3 µg). Although these previous studies demonstrate reduced rescue analgesic in postoperative period in either gabapentin group or pregabalin group, they had analyzed these two drugs separately. None had done the comparative study between these two drugs on postoperative opioids consumption, except Saraswat and Arora,[17] who found that the total dose of analgesic (even though not opioid) in the 1st 24 h postoperatively was 62.5 mg in pregabalin group and 72.5 mg in gabapentin group and the difference was not statistically significant in contrast to the present study. The difference in these two studies might be due to different doses of the study drugs and type of rescue analgesic given and also the type of anesthesia provided (spinal vs. general anesthesia).

In our study, we had used a single oral dose of 900 mg gabapentin and 150 mg pregabalin, which was administered 1 h prior to the procedure. The doses and duration between administrations were comparable in all the three groups. Most of the workers have used either gabapentin 1200 mg like in radical mastectomy,[18] ENT surgery or they have used 600 mg gabapentin like in percutaneous nephrolithotomy,[19] surgery for brachial plexus injury [20] and few of them had used gabapentin 300 mg like in laparoscopic cholecystectomy.[11],[21] In our study, the gabapentin dose is 900 mg, which lies in between the two extreme doses, the reason for our selection was that smaller dose of gabapentin has no role in postoperative pain if given 1 h before surgery as seen in Gregg et al.[21] study of role of gabapentin 300 mg in laparoscopic cholecystectomy. The dose of pregabalin also varies from 75 to 450 mg in different studies, the studies in accordance with this study using pregabalin 150 mg were Reuben et al.[22] in decompressive lumbar laminectomy with posterior spinal fusion surgery and Agarwal et al.[12] in laparoscopic cholecystectomy. We preferred to use 1 h for the patient and surgeon's convenience and also the study drug reaches almost its peak plasma concentration in 1 h.[23],[24]

The side effects seen in this study were sedation, nausea and vomiting, respiratory depression, vertigo in all the three groups. No significant statistical difference in number of patients with side effects was found among all the three groups.


   Conclusion Top


In this study, it can be concluded that both gabapentin and pregabalin have significant role in postoperative analgesia, but pregabalin 150 mg must be a better choice compared to gabapentin 900 mg for postoperative analgesia in laparoscopic cholecystectomy cases under general anesthesia.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5]


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