| CTRI Number |
CTRI/2025/07/091732 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing two types of nerve blocks given before surgery to reduce pain after gallbladder removal under general anaesthesia. |
|
Scientific Title of Study
|
Preemptive Ultrasound guided Modified Thoracoabdominal nerve block via perichondrial approach (M - TAPA) vs oblique subcostal transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia - A Randomised controlled trial |
| 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 Deepak Vijaykumar Kadlimatti |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9008229914 |
| Fax |
|
| Email |
deepakkadlimatti@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Deepak Vijaykumar Kadlimatti |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9008229914 |
| Fax |
|
| Email |
deepakkadlimatti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Deepak Vijaykumar Kadlimatti |
| Designation |
Associate Professor |
| Affiliation |
Dr B R Ambedkar medical college and hospital |
| Address |
Department of Anaesthesiology Dr B R Ambedkar medical college and hospital Shampura main road Kadugondanahalli Bangalore
Bangalore KARNATAKA 560045 India |
| Phone |
9008229914 |
| Fax |
|
| Email |
deepakkadlimatti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar medical college and hospital. Shampura main road. Kadugondanahalli. Bangalore 560045 |
|
|
Primary Sponsor
|
| Name |
Dr B R Ambedkar medical college and hospital |
| Address |
Ot complex, Dr B R Ambedkar medical college and hospital, Shampura main road, Kadigondanahalli, Bangalore 560045 |
| 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 Deepak Vijaykumar Kadlimatti |
Dr B R Ambedkar medical college and hospital |
Ot complex, Department of anaesthesiology, Dr B R Ambedkar medical college and hospital, Shampura main road, Kadigondanahalli, Bangalore 560045 Bangalore KARNATAKA |
9008229914
deepakkadlimatti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Dr B R Ambedkar medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilateral Modified Thoracoabdominal nerve block through perichondrial approach for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
Group A will receive ultrasound guided Modified Thoracoabdominal nerve block through perichondrial approach at 10th costal costochondral junction with Inj Bupivacaine (0.25%) 20ml with Inj Dexamethasone 4mg |
| Comparator Agent |
Bilateral Oblique Subcostal Transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia |
Group B will receive ultrasound guided Oblique Subcostal Transversus abdominis plane block to transversus abdominis fascia with Inj Bupivacaine (0.25%) 20ml with Inj Dexamethasone 4mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective laparoscopic cholecystectomy under general anaesthesia.2. Patients aged between 18 to 75y.3. Patients belonging to American Society of Anaesthesiologists physical status (ASA - PS) 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Known allergy to the local anaesthetics given.
2. Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
3. Patients with dementia or cognitive problems.
4. Patients with BMI more than 35 kg/m2.
5. Coagulopathy or patients on anti-coagulants
6. Patients who are known case of diabetes mellitus. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups |
The time period from administration of block till first rescue analgesia for first 24 postoperative hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare total analgesic consumption during postoperative period over 24 hours in both groups.
To assess the adverse effects associated with analgesics such as nausea, vomiting. |
Time of administration of block to 24 postoperative hours |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
04/08/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Laparoscopic cholecystectomy (LC)
is a frequently performed surgery as the gold standard in the treatment of
symptomatic gallstone disease. Despite the introduction of a minimally invasive approach, cholecystectomy
can cause significant postoperative pain owing to multifactorial factors. Acute postoperative pain is the most common cause of patient discomfort during the
period after LC and is the most common cause of readmission after discharge. Poorly controlled postoperative pain impairs the quality of recovery,
increasing the risk of postoperative pulmonary complications as risk factor for
the formation of chronic pain. It was observed that the abdominal pain
following LC mostly originates from the incision area, and the remaining part
consists of visceral and referred pain. Multimodal analgesia, including opioids
is used to limit pain following LC. Treatment with opioids might cause side
effects for example postoperative nausea and vomiting, constipation,
respiratory depression. Oblique subcostal transverse
abdominis plane block (OSTAP) provides a wide range of analgesia from T7 – T12,
is effective for 6 – 18h postoperatively, however it requires multiple
injections to achieve complete analgesia. Modified thoracoabdominal nerve
block through perichondrial approach (M – TAPA)
is a newer technique which has received increasing attention due to its
wide range of analgesic coverage of the trunk (that is T5 – T12) with a single puncture per side and has
been reported to provide a long acting
effect. M – TAPA offers blocking both anterior and lateral cutaneous branches
of the thoracoabdominal nerves, surpassing the limitations of conventional
techniques such as transversus abdominis plane block. We hypothesize that M – TAPA block
would be more effective than OSTAP block for controlling postoperative pain,
considering its range of efficacy and long term durability. |