| CTRI Number |
CTRI/2020/08/027342 [Registered on: 24/08/2020] Trial Registered Prospectively |
| Last Modified On: |
21/08/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
|
Scientific Title of Study
|
To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lakshmi Mahajan |
| Designation |
Associate Professor |
| Affiliation |
SGRDIMSAR |
| Address |
Anaesthesia Department,
SGRDIMSAR
Amritsar
Department of Anaesthesia,
SGRD city Hospital,
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
7986469143 |
| Fax |
|
| Email |
drlakshmimahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anita Kumari |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Anaesthesia Department,
SGRDIMSAR
Amritsar
Anaesthesia Department,
SGRDIMSAR,
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9815632909 |
| Fax |
|
| Email |
kumarianitadr1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suzen Sumeet Kaur |
| Designation |
Junior Resident |
| Affiliation |
SGRDIMSAR |
| Address |
Department of Anaesthesia,
SGRDIMSAR,
Amritsar
Anaesthesia Department,
SGRDIMSAR,
Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
7986858015 |
| Fax |
|
| Email |
suzen.sandhu69@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Ruchi Gupta |
SGRDIMSAR |
Operation Theatre, Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB |
9814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperitoneal instillation of drugs |
Ropivacaine and butorphanol versus ropivacaine and nalbuphine instillation after removal of gall bladder |
| Comparator Agent |
ropivacaine and butorphanol versus ropivacaine and nalbuphine |
20 ml of 0.2% ropivacaine along with 2 mg butorphanol in group A, 20 ml of 0.2% ropivacaine along with 10 mg nalbuphine in group B and 20 ml of 0.2% ropivacaine along with 0.9% normal saline in group C will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II.
2. Elective laparoscopic cholecystectomy.
|
|
| ExclusionCriteria |
| Details |
1. Acute cholecystitis.
2. Carcinoma Gall bladder.
3. Hypersensitivity to study drugs.
4. Pregnant females.
5. Bleeding disorders.
6. Opioid addicts.
7. Patient refusal to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia. |
After extubation of patient till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the timing of first request and frequency of rescue analgesia. |
After extubation of patient till 24 hours. |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2020 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Post-operative
pain after laparoscopic cholecystectomy is avery common complication hindering
early return of routine activity. In various studies intraperitoneal
instillation of local anaesthetics have been shown to be safe, effective and
minimally invasive and opioids have shown to have a synergestic effect.
Ropivacaine is shown to be more safe and efficacious as compared to other local
anaesthetics such as bupivacaine. Similarly, nalbuphine is better than other
opioids due to its mixed action on opioid receptors. Since agonist opioids are
not available with us, the most common drug used for intraoperative analgesia
is IV butorphanol. So the purpose of our study is to compare the effect of intraperitoneal
butorphanol with intraperitoneal nalbuphine for laparoscopic cholecystectomy. |