跳至主要内容
临床试验/CTRI/2012/02/002425
CTRI/2012/02/002425已完成Phase 3 4

Effect of pre-operative Gabapentin on early post operative pain, nausea, vomiting and analgesic consumption following laparotomy in AGMC & G B P Hospitalâ€

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年8月21日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
入组人数
80
试验地点
1
主要终点
pain score by Visual analogue scale (VAS)

研究概览

简要总结

Prevention and control of post operative pain, nausea, and vomiting continues to be a major challenge in post operative care. Opioid analgesics and NSAIDS continues to represent a cornerstone in post operative pain control and testing new analgesics in order to reduce the need for opioids, is a key area in acute pain research. Gabapentin has been used in the treatment of neuropathic pain as well as post operative pain with good result. Gabapentin have demonstrated analgesic effect in clinical trials as a preemptive analgesic and in acute post operative pain management; however experience with gabapentin is limited.

This study was designed to compare the effcts of small dose of oral Gabapentin with placebo as pre medication on early post operative pain, nausea, vomiting, total analgesic consumption in patients undergoing elective laparoscopic cholecystectomy in AGMC and GBP Hospital.

A prospective, double blind, randomized study was conducted among 80 patients undergoing elective cholecystectomy. The patients were divided into two groups having 40 patients each of either sex and were randomly assigned to receive oral Gabapentin 300 mg or placebo as pre medication 2 hr before surgery. Patients were anaesthetized with the same anesthetic techniques and pre medications. Severity of pain, nausea, vomiting and total analgesic consumption was compared between the study groups.

Demographic data were not statistically different between study groups. There were significant differences in median VAS scores measurements at all time points. In placebo group the pain score (Mean ± SEM) in VAS at 2, 6, & 24 hrs was (57.0 ± 1.7), (43.5 ±1.7), (34.2 ± 3.0) respectively. But statistically significant less pain score (39.7 ± 2.0) (p<0.001), (25.5 ± 2.0) (p<0.001), (23.2 ± 3.1) (p<0.05) was observed in Gabapentin group at 2, 6, & 24 hrs respectively. Total dose of analgesic consumption in Gabapentin group was (0.90 ± 0.04, 1.2 ± 0.7, 1.6 ± 0.12) respectively in 2, 6 & 24 hrs post operatively. Whereas in the placebo group it total dose of analgesic consumption was (1.0 ± 0.00), (1.8 ± 0.07), (2.50 ± 0.13) at 2, 6 and 24 hour respectively postoperatively which are statistically higher than gabapentin group. There is no statistically significant difference of nausea at 2hr and 6hr and vomiting at 2, 6 & 24 hours between Gabapentin and placebo group subjects. Only at 24 hrs nausea was significantly less (p<0.05) in gabapentin group. No patient in any group reported any adverse effect like somnolence, ataxia, lightheadedness, pruritus or visual disturbances. Only in 2 patients in each group there was complain of drowsiness which disappeared with continued therapy. To conclude, this study showed that pre operative administration of low dose Gabapentin 300 mg 2 hrs before cholecystectomy surgery decreased post operative pain, nausea and total analgesic consumption and delayed the need of supplementary analgesics with a very minimal insignificant adverse effects suggesting that gabapentin has clinical potential in the treatment of post operative pain without significant side effects.

Reference: 1. Mohammadi S S & Seyedi M . Effect of Gabapentin on early post operative pain, nausea and vomiting in laparoscopic surgery for assisted reproductive technologies. Pak. J.Bio.Sci 2008; 11 (14): 1878-1889. 2. Sekhabat L, Zare F, Mojibian M. The post operative analgesic effects of low dose gabapentin in patients undergoing abdominal hysterectomy. South African J Obs. & Gynae. 2009; 15: down loaded from http: // findarticles.com/ p/articles/ mi on 20th Jan 2011.

3.Straube S, Derry S, Moore RA, Wiffen PJ, McQuay HJ. Single dose oral gabapentin for established acute post operative pain in adults. Downloaded from hptt;// www.2.cochrane.org/reviews/en on 21st Jan 2011. 4. Pandey C K , Priye S , Singh S, SinghU Singh R B & Singh P K. Preemptive use of gabapentin significantly decreases postoperative pain and rescue analgesic requirements in laparoscopic cholecystectomy. CAN J ANASTH 2004; 51:4: 358-363.

5.Bang SR, Yu SK, Kim TH. Can gabapentin help reduce post operative pain in arthroscopic rorator culf repair? A prospective, randomized, double blind study. Arthoscopy 2010; 26(9suppli): S 106 – 11.

6.Jens B, Karen LH, Nils CH, Jens E, Joergen BD. Effect of gabapentin on morphine demand and pain after laproscopic sterilization using filshie clips. A double blind randomized clinical trial. BMC Aneasthesiol 2006; 6: 12.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • 18 yrs or older.
  • Patient with American Society of Anesthesiologists (ASA) classification grade I & Grade II will be included.
  • Undergoing elective laparotomy under general anesthesia.

排除标准

  • 1.Patients with present history of pregnancy.
  • 2.Patients with history of epilepsy or chronic pain, or use of anti epileptic drugs or neuropathic analgesics.
  • Patient with American Society of Anesthesiologists (ASA) classification of 3 or greater.
  • 4.Patients with a history of opioid or intravenous drug abuse.
  • 5.Patients with known allergy to gabapenin.
  • 6.Patients who have taken antacid medication in the previous 24 hrs.
  • 7.Patients who refused general anesthesia.

结局指标

主要结局

pain score by Visual analogue scale (VAS)

时间窗: At 2hr 6 hour and 24 hour post operatively

次要结局

  • 1. Post Operative Nausia Vomitting, drowsiness, & pruritus.(2. Total dose of analgesic consumption.)

研究者

申办方类型
Government funding agency

研究点 (1)

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