| 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
|
|
|
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. |