| CTRI Number |
CTRI/2020/11/028869 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Postoperative pain relief and analgesia after laproscopic cholecystectomy: bupivacaine versus nalbuphine ,when instilled through the laprpscopic port
|
|
Scientific Title of Study
|
Postoperative pain relief after laproscopic cholecystectomy: intraperitoneal bupivacaine versus nalbuphine
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAMIKSHA KHANUJA |
| Designation |
Assistant Professor |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Hamdard Institute of Medical Sciences,New Delhi
South
DELHI
110062
India |
| Phone |
702397398 |
| Fax |
|
| Email |
ssajr123@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SAMIKSHA KHANUJA |
| Designation |
Assistant Professor |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Hamdard Institute of medical sciences, New Delhi
South
DELHI
110062
India |
| Phone |
702397398 |
| Fax |
|
| Email |
ssajr123@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
SAMIKSHA KHANUJA |
| Designation |
Assistant Professor |
| Affiliation |
Hamdard Institute Of Medical Sciences,New Delhi |
| Address |
Hamdard Institute of medical sciences, New Delhi
South
DELHI
110062
India |
| Phone |
702397398 |
| Fax |
|
| Email |
ssajr123@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Hamdard Institute of medical sciences and Hakeem Abdul Centenary Hospital,New Delhi |
|
|
Primary Sponsor
|
| Name |
Hakeem Abdul Centenary hospitalNew Delhi |
| Address |
Hamdard Institute of medical Sciences and Hakeem Abdul Centenary hospital,New Delhi 110062 |
| 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 Kharat Mohd Batt |
Hakeem Abdul Centenary hospital, New Delhi |
Operating room,8th floor,New block
South
DELHI |
9622457554
khairatm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-HIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
bupivacaine |
bupivacaine 0.5% 20 ml instilled intraperitoneally |
| Intervention |
nalbuphine |
nalbuphine 10 mg to be instilled intraperitoneally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Eighty patients ( 40 in each group) with ASA 1,2, aged 18-60 years, undergoing laproscopic cholecystectomy were be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients with H/o chronic opioid intake
Known allergy to local anaesthetics,
Obese or pregnant patients were excluded from the study.
Patients those who have chronic pain diseases (not related to choleystitis) or have acute cholecystitis before the surgery were also be excluded
When the duration of surgery exceeded 2 hrs or if the surgery got converted to open, were also excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare and assess the VAS score at different intervals and to determine the time of first analgesic request. |
post operative ,2 ,4 ,6 hrs upto 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the analgesic request rate ( number of doses of tramadol in 24 hrs), patient satisfaction score , incidence of shoulder pain and time to return to normal activity. |
uptl 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
05/11/2020 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study was
to compare the effectiveness of intraperitoneal bupivacaine and intraperitoneal
nalbuphine for postoperative pain relief after laproscopic cholecystectomy. |