| CTRI Number |
CTRI/2019/07/019969 [Registered on: 01/07/2019] Trial Registered Prospectively |
| Last Modified On: |
28/06/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the effectiveness of administering ketamine, levo-bupivacaine and a combination of both into the abdominal cavity for reducing post surgical pain in patients after keyhole surgery for gall bladder removal |
|
Scientific Title of Study
|
A comparative study to evaluate the effectiveness of intraperitoneal instillation of ketamine, levo-bupivacaine and both for postoperative analgesia in patients undergoing laparoscopic cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1235-1267 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DERLIN THOMAS |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Amala Institute of Medical Sciences,
Thrissur
Amala Medical college,
Amalanagar,
Thrissur,
Kerala
Thrissur
KERALA
680555
India |
| Phone |
09447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DERLIN THOMAS |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Amala Institute of Medical Sciences,
Thrissur
Amala Medical college,
Amalanagar,
Thrissur,
Kerala
Thrissur
KERALA
680555
India |
| Phone |
09447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DERLIN THOMAS |
| Designation |
Assistant Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Amala Institute of Medical Sciences,
Thrissur
Amala Medical college,
Amalanagar,
Thrissur,
Kerala
Thrissur
KERALA
680555
India |
| Phone |
09447768944 |
| Fax |
|
| Email |
derlin.t@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences, Thrissur, Kerala, India |
|
|
Primary Sponsor
|
| Name |
Amala Institute of Medical Sciences |
| Address |
Amalanagar,
Thrissur,
Kerala, INDIA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Derlin Thomas |
Amala Institute of Medical Sciences |
1st Floor,
Dept of Anesthesiology,
Amala Institute of Medical Sciences,
Amalanagar,
Thrissur,
Kerala, INDIA
Thrissur
KERALA |
09447768944
derlin.t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amala Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A |
Group A: will receive intraperitoneal instillation with ketamine 0.5mg/kg diluted with saline to make a total of 30 ml. |
| Intervention |
GROUP B |
Group B :will receive intraperitoneal instillation of 0.5% levo-bupivacine at 2mg/kg diluted with saline to make a total of 30 ml |
| Intervention |
GROUP C |
Group C : will receive intraperitoneal instillation of a combination of 0.5% levo-bupivacaine at 2mg/kg and ketamine 0.5mg/kg, diluted with saline to make a total of 30 ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex,between age 18 years-70years,ASA physical status 1-3,who are scheduled for laparoscopic cholecystectomy under General Anesthesia and are willing and able to give informed consent will be recruited to the trial |
|
| ExclusionCriteria |
| Details |
Patients were excluded if
1. they had a clinical diagnosis of acute pancreatitis
2. acute preoperative pain other than biliary colic
3. chronic pain treatment
4. anti-epileptic therapy
5. history of alcohol or drug addiction
6. severe hepatic or renal impairment
7. allergy to the study drugs
8. cognitive impairment or communication problems
9. pregnant or lactating
10. conversion to open cholecystectomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
24 hour total rescue analgesic (diclofenac +/-tramadol) consumption
|
at 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of postoperative pain scores,Time to first requirement of rescue analgesia, time to unassisted ambulation and Tolerability of the used doses represented by the side effects. |
At 6h 12h and 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Pain is a consistent and predominant complaint of many individuals after surgical interventions.Failure to relieve pain is morally and ethically unacceptable.Laparoscopic cholecystectomy has improved surgical outcome in terms of reduced pain,morbidity and duration of convalescence compared to open cholecystectomy.However laparoscopic cholecystectomy is not entirely a pain free procedure.Hence, in this prospective, randomized, double-blind clinical trail we are evaluating and comparing the efficacy of intraperitoneally instilled ketamine,levo-bupivacaine and its combination in alleviating post operative pain after laparoscopic cholecystectomy.The primary objective of the study is to evaluate and compare the effectiveness of the study drugs in reducing total analgesic consumption for 24 hours post operatively. The secondary objective is to assess reduction in post op pain scores, time to first requirement of rescue analgesia, time to unassisted ambulation and tolerability of the used study drugs represented by side effects during the first 24 hours post operatively.Static pain (at rest) and Dynamic pain (deep breathing) will be assessed at 6, 12 and 24 hours post operatively using a Numerical Rating Scale (NRS).
|