| CTRI Number |
CTRI/2026/02/104558 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| 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 Pain and Recovery After Opioid-Based and Opioid-Free Anaesthesia for Laparoscopic Gallbladder Surgery |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED TRIAL TO COMPARE THE POST-OPERATIVE PAIN AND RECOVERY CHARACTERISTICS USING CONVENTIONAL OPIOID BASED VERSUS OPIOID FREE ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY |
| 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 Akash Jain |
| Designation |
Secondary DNB Student |
| Affiliation |
Dr. Baba Saheb Ambedkar Medical College and Hospital, Rohini, Delhi |
| Address |
4th Floor, Building No - 102, Bahubali Enclave, Karkardooma, East Delhi
North West
DELHI
110092
India |
| Phone |
9899897439 |
| Fax |
|
| Email |
drakashjain1061@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nidhi Prabha Sehgal |
| Designation |
Consultant Specialist, Assisstant Professor |
| Affiliation |
Dr. Baba Saheb Ambedkar Medical College and Hosppital |
| Address |
G-117, New Saraswati CGH Society, Sector - 9, Rohini
North West
DELHI
110085
India |
| Phone |
9899897439 |
| Fax |
|
| Email |
doc_nidhi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Prabha Sehgal |
| Designation |
Consultant Specialist, Assisstant Professor |
| Affiliation |
Dr. Baba Saheb Ambedkar Medical College and Hosppital |
| Address |
G-117, New Saraswati CGH Society, Sector - 9, Rohini
North West
DELHI
110085
India |
| Phone |
9899897439 |
| Fax |
|
| Email |
doc_nidhi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Baba Saheb Ambedkar Medical College and Hospital, Rohini, Delhi - 110085 |
|
|
Primary Sponsor
|
| Name |
Dr Baba Saheb Ambedkar Medical College and Hospital |
| Address |
Sector - 6, Rohini, Delhi - 110085 |
| 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 Akash Jain |
Dr. Baba Saheb Ambedkar Hospital |
Operation Theatre and Post-Op Room, Main OT Complex, 2nd Floor, Hospital Building, Sector- 6, Rohini, Delhi - 110085
North West
DELHI |
9899897439
drakashjain1061@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Baba Saheb Ambedkar Hospital |
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 |
| Comparator Agent |
DEXMEDETOMIDINE |
Each patient will receive dexmedetomidine at a loading dose of 0.5 µg/kg (prepared as 2 µg/ml) administered intravenously over 10 minutes prior to induction of anaesthesia. At the time of induction, ketamine will be administered at an analgesic dose of 0.35 mg/kg intravenously. Following creation of pneumoperitoneum, dexmedetomidine infusion (prepared as 1 ml = 2 µg) will be started and maintained at a rate of 0.15 ml/kg/hour (equivalent to 0.3 µg/kg/hour) until the completion of surgery. Additionally, after creation of pneumoperitoneum, a bilateral subcostal laparoscopic-guided transversus abdominis plane (TAP) block will be performed using 10 ml of 0.25% plain bupivacaine combined with 10 ml of 1% plain lignocaine on each side (total volume 20 ml per side). |
| Intervention |
FENTANYL |
2 micrograms per kg body weight intravenously at the time of induction during general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age :18-60 years of both gender
2. American Society of Anesthesiologists (ASA) physical status I and II
3. BMI : 18.5-30 kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Patient with known case of coagulopathy, cardiovascular, hepatic, pulmonary, psychological or neurological diseases
2. History of psychiatric illness or inability to assess pain
3. Patient allergic to study drugs
4. Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing post-operative pain using opioid free anesthesia (intravenous dexmedetomidine , ketamine and laparoscopic guided transversus abdominis plane block) versus conventional opioid based anesthesia for laparoscopic cholecystectomy with the help of Visual Analogue Scale every 4 hours and total amount of analgesic required in 1st 24 hours |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare both groups regarding recovery characteristics -
1) Time taken for extubation
2) Post-operative sedation score (Modified Ramsay Sedation Scale)
3) Incidence of PONV (Verbal Rating Scale)
4) Patient satisfaction (QoR-15 Scale) |
3 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
05/03/2026 |
| 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="3"
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
|
Currently, there is a paucity of randomized controlled trials that directly compare the efficacy of conventional opioid-based anaesthesia with OFA incorporating laparoscopic TAP blocks during laparoscopic cholecystectomy in terms of postoperative pain control, recovery metrics, opioid consumption, PONV, and patient satisfaction. Therefore, this study is being done to contribute supportive evidence to the existing literature on whether an opioid free anaesthesia approach incorporating laparoscopic-guided TAP block provides superior postoperative outcomes compared to the conventional opioid based anesthesia in laparoscopic cholecystectomy.
Study area: The study will be conducted in the operation theatre complex, Department of Anaesthesiology & Critical care at Dr. Baba Saheb Ambedkar Medical college and Hospital, Sector-6, Rohini, Delhi.
Primary Objective: Comparing post-operative pain using opioid free anesthesia (intravenous dexmedetomidine , ketamine and laparoscopic guided transversus abdominis plane block) versus conventional opioid based anesthesia for laparoscopic cholecystectomy using – a) Visual Analogue Scale (VAS) every 4 hour till 24 hours b) Total amount of analgesic requirement in 24 hours
Secondary Objectives: Compare both groups regarding: 1) Time taken for extubation 2) Post-operative sedation score (Modified Ramsay Sedation Scale) 3) Incidence of PONV (Verbal Rating Scale) 4) Patient satisfaction (QoR-15 Scale) |