| CTRI Number |
CTRI/2023/07/055685 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
22/07/2023 |
| 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
|
To compare modified thoracoabdominal nerve block via perichondral approach with port site local infiltration for post operative analgesia after laparoscopic cholecystectomy: a randomized controlled study |
|
Scientific Title of Study
|
Comparison of modified thoracoabdominal nerve block via perichondral approach with port site local infiltration for post operative analgesia after laparoscopic cholecystectomy : a randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Chaudhary |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Room no-417, third floor , Department of Anaesthesiology, BL Taneja block , Maulana Azad Medical College, Delhi
Central
DELHI
110002
India |
| Phone |
9958607966 |
| Fax |
|
| Email |
chaudharyshalini33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Room no. 417 , third floor , Department of Anaesthesiology, BL Taneja Block , Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Chaudhary |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College and associated hospitals |
| Address |
Room no 417, third floor , Department of Anaesthesiology, BL Taneja block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9958607966 |
| Fax |
|
| Email |
chaudharyshalini33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College , Lok Nayak hospital and associated hospitals.
Bahadur Shah Zafar marg
New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College and associated hospitals, Bahadur Shah Zafar Marg , New Delhi -110002 |
| Type of Sponsor |
Government 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 Shalini Chaudhary |
Lok Nayak Hospital |
Department of Anaesthesiology, BL taneja block, Maulana Azad Medical College, Lok Nayak Hospital, JLN marg , Delhi
Central
DELHI |
9958607966
chaudharyshalini33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , Maulana Azad Medical College |
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 Infiltration |
After induction of patient,20ml 0f 0.25% bupivacaine will be infiltrated into the skin and subcutaneous tissue of the port sites. Post surgery patient will be monitored for 24 hours |
| Intervention |
Modified Thoracoabdominal Nerve Block via perichondral approach (mTAPA) |
The mTAPA block will be performed after induction of the patient in supine patient by an experienced anaesthesiologist.The USG probe will be placed in saggital plane in the subcostal area and angled deeply to identify the lower aspect of 10th costal cartilage. An ultrasound needle (21guaze,100mm) will be inserted via an in plane technique and needle tip will be advanced in the plane of ultrasound beam till it reaches between 10th costal cartilage and transverse abdominus plane at the lower aspect of chondrum . The correct positioning will be confirmed by hydro dissection and after confirmation 20ml of 0.25% bupivacaine will be injected in the plane. The patient will be monitored for 24 hours post surgery.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients from 18 to 65 years of age belonging to American Society of Anaesthesiology (ASA) physical health status I- III |
|
| ExclusionCriteria |
| Details |
1. Contraindications to nerve block like coagulopathies and local site pathology
2. Body mass index>35%
3.Pregnant patients
4. Any allergy to study medications |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain score after 24 hours of laparoscopic cholecystectomy at rest & at movement.
2. Proportion of patients requiring rescue analgesia in 24 hours after surgery. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to request for first rescue analgesia.
2. Total consumption of opioids at 24 hours postoperatively.
3. NRS at 2,4,6 & 12 hours after surgery at rest and at movement.
4. Number of patients reporting nausea ,vomiting, sedation and pruritis.
5. Quality of recovery at 24 hours post operatively. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
04/08/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are comparing modified thoracoabdominal nerve block via perichondral approach (mTAPA ) block with port site local infiltration for post operative analgesia in patients posted for laparoscopic cholecystectomy in Lok Nayak Hospital, Delhi. A total of 46 patients with 23 patients in each group will be enrolled in the study. Patients will be explained about the study and written informed consent will be taken. We will be using standard general anaesthesia for induction of the patients following which ultrasound guided block site will be identified and local anaesthetic drig will be given.Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain , post operative nausea vomiting , sedation and quality of recovery will be noted. |