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CTRI Number  CTRI/2012/02/002425 [Registered on: 15/02/2012] Trial Registered Retrospectively
Last Modified On: 15/02/2012
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to see the effect of gabapentin in pain management after operation 
Scientific Title of Study   Effect of pre-operative Gabapentin on early post operative pain, nausea, vomiting and analgesic consumption following laparotomy in AGMC & G B P Hospital” 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Samiksha Bhattacharjee 
Designation  2nd Prof MBBS Student 
Affiliation  Agartala Govt. Medical College 
Address  Department of Pharmacology Agartala Govt Medical College Po Kunjaban Agartala Tripura

West Tripura
TRIPURA
799006
India 
Phone  09774429767  
Fax  0381-2356701  
Email  samagmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Debasis Ray 
Designation  Assistant Professor 
Affiliation  Agartala Govt Medical College 
Address  Department of Pharmacology Agartala Govt Medical College Po Kunjaban Agartala Tripura

West Tripura
TRIPURA
799006
India 
Phone  09436125100  
Fax  0381-2356701  
Email  contactdebasisray@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Debasis Ray 
Designation  Assistant Professor 
Affiliation  Agartala Govt Medical College 
Address  Department of Pharmacology Agartala Govt Medical College Po Kunjaban Agartala Tripura

West Tripura
TRIPURA
799006
India 
Phone  09436125100  
Fax  0381-2356701  
Email  contactdebasisray@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  Division of BMS Indian Council of Medical Research V. Ramalingaswami Bhawan Ansari Nagar New Delhi 110029 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Dr Debasis Ray  Department of Pharmacology Agartala Govt. Medical College Po Kunjaban 799006 Tripura West 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Debasis Ray  Surgical ward including Pre and Post operative care room  Agartala Govt Medical College Po Kunjaban Agartala
West Tripura
TRIPURA 
09436125100
0381-2356701
contactdebasisray@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutinal Ethics Committee AGMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients under going laparotomy operation under General Anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gabapentin  300mg once orally 2 hour before general anaesthesia 
Comparator Agent  Placebo  Placebo of gabapentin orally 2 hour before anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. 18 yrs or older.
2. Patient with American Society of Anesthesiologists (ASA) classification grade I & Grade II will be included.
3. Undergoing elective laparotomy under general anesthesia. 
 
ExclusionCriteria 
Details  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.
3. 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. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
pain score by Visual analogue scale (VAS)   At 2hr 6 hour and 24 hour post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Post Operative Nausia Vomitting, drowsiness, & pruritus.
2. Total dose of analgesic consumption.
3.Time of 1st request of the patient for analgesics. 
at 2, 6 & 24 hours after operation 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   21/08/2011 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

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.

 
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