| CTRI Number |
CTRI/2023/04/052035 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of ultrasound guided blocks with local infiltration for pain relief in post operative patients undergoing laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of combined External oblique intercostal and Rectus sheath block with local infiltration analgesia at port site in patients undergoing Laparoscopic cholecystectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnovi Gangadhar |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
Department of Anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7259303000 |
| Fax |
|
| Email |
dr.vaishnovi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Saini |
| Designation |
Professor |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
Department of anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9891228793 |
| Fax |
|
| Email |
drsainisumannony@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishnovi Gangadhar |
| Designation |
Post graduate resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
Department of Anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
7259303000 |
| Fax |
|
| Email |
dr.vaishnovi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman Mahavir medical college and Safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhaman Mahavir medical college and Safdarjung hospital |
| Address |
VMMC and Safdarjung hospital,
Ansari nagar, New Delhi. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vaishnovi Gangadhar |
Safdarjung hospital |
Department of Anaesthesiology and intensive care,VMMC and SJH, Ansari Nagar East, near AIIMS metro station, New Delhi 110029
New Delhi
DELHI |
7259303000
dr.vaishnovi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
Local infilteraltion analgesia at port site |
Adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia will be given LIA for post operative analgesia and observed for next 24 hours |
| Intervention |
Ultrasound guided combined External oblique intercostal and Rectus sheath block |
Adult patients undergoing elective laparoscopic cholecystectomy under general anaesthesia will be given intervention for post operative analgesia and observed for next 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA status I and II undergoing laparoscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. history of allergy or hypersensitivity to local anaesthetics
2. contraindications to block
3. inability to understand pain scale.
4. BMI > 30 kg/m2
5. Pregnancy
6. pulmonary, Cardiac, Hepatic and renal diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the analgesic efficacy of combined External Oblique intercostal and Rectus Sheath block with loacl infilteration of analgesia at port site for post operative analgesia in patients undergoing laparoscopic cholecystectomy. |
1 hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. compare and evaluate VAS at 2,4,6,8,12 and 24 hours.
2. time to rescue analgesia.
3. cummulative 24 hour analgesia requirement.
4. patient satisfaction using Likert scale. |
1. compare and evaluate VAS at 2,4,6,8,12 and 24 hours.
2. time to rescue analgesia.
3. cummulative 24 hour analgesia requirement.
4. patient satisfaction using Likert scale. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/05/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, interventional randomised comparitive study conducted in the Department of Anaesthesiology and intensive care, VMMC and Safdarjung hospital to compare the analgesic efficacy of combined External oblique intercostal and rectus sheath block with local infilteration of analgesia at port site for post operative analgesia in ASA grade I and II patients undergoing laparoscopic cholecystectomy with the hypothesis that combined External oblique intercostal and rectus sheath block is superior to local infilteration of analgesia at port site. Primarily post operative VAS score will be recorded at 1 hour. Secondarily, VAS at 2, 4, 6, 8, 12 and 24 will be recorded along with cummulative 24 hour analgesia requirement and time to first rescue analgesia. |