| CTRI Number |
CTRI/2026/02/102868 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ultrasound-guided pain relief methods in patients undergoing laparascopic gallbladder removal surgery |
|
Scientific Title of Study
|
Comparison of postoperative analgesic efficacy of ultrasound guided modified
thoracoabdominal nerve block through perichondrial approach versus ultrasound guided
subcostal TAP block in patients undergoing laparoscopic
cholecystectomy in a tertiary care centre a randomized 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 |
Keerthikaa M |
| Designation |
Junior resident |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Anesthesiology,Kasturba Hospital,Kasturba Medical College, Manipal,MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9489116070 |
| Fax |
|
| Email |
keerthikaa.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rama Rani K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Kasturba Medical College, Manipal |
| Address |
Department of Anesthesiology,Kasturba Hospital,Kasturba Medical College, Manipal,MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
rama.rani@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rama Rani K |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Hospital, Kasturba Medical College, Manipal |
| Address |
Department of Anesthesiology,Kasturba Hospital,Kasturba Medical College, Manipal,MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9902938044 |
| Fax |
|
| Email |
rama.rani@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Kasturba Medical College, Manipal, Udupi, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Keerthikaa M |
| Address |
Department of Anesthesiology, Kasturba Hospital, Kasturba Medical College, Manipal, Udupi, Karnataka-576104 |
| 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 Keerthikaa M |
Kasturba Hospital, Kasturba Medical College |
Department of Anesthesiology, Kasturba Hospital, Kasturba Medical College, Manipal, Udupi, Karnataka-576104
Udupi
KARNATAKA |
9489116070
keerthikaa.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K851||Biliary acute pancreatitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (4) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (5) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (6) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (7) ICD-10 Condition: K830||Cholangitis, (8) ICD-10 Condition: K81||Cholecystitis, (9) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, (10) ICD-10 Condition: K820||Obstruction of gallbladder, (11) ICD-10 Condition: K828||Other specified diseases of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modified Thoracoabdominal Nerve Block Through Perichondrial Approach |
Deposition of local anaesthetics into lower aspect of perichondrium of 10th rib at costochondral angle.The procedure will done over a period of 10 minutes. |
| Comparator Agent |
Ultrasound guided subcostal transversus abdominis plane block |
Deposition of local anesthetic between internal oblique and transversus abdominis muscles under ultrasound guidance at the end of surgery. The procedure will done over a period of 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18-70 years undergoing elective laparoscopic cholecystectomy .
2. American Society of Anaesthesiologists (ASA) physical status classification I-II.
3.Patients willing to participate in the study and provide informed consent with ability to
understand and comply with study procedures and assessments. |
|
| ExclusionCriteria |
| Details |
1.Patients with a history of allergy to the local anaesthetics used in the blocks.
2. Pregnant patients and patients with BMI more than 35kg/m2
3. Patients with infection at the needle puncture site. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of pain (NRS) at 0, 1, 6, 12, 24 hours after block.Time of 1st analgesic requirement.
Total analgesic consumption in 1st 24 hrs post surgery. |
To compare the Numerical Rating Scale (NRS) score at rest in patients during the first
postoperative 24 hours between the study groups.
To compare the time to first rescue analgesic requirement between the study groups.
To compare the postoperative 24 hours analgesics consumption between the study
groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PONV at 0, 1, 6, 12, 24 hours.
Adverse effects of block. |
Patients
will be assessed at specified intervals by the postgraduate during the postoperative period:
immediately upon arrival at the PACU, & at 6, 12, & 24 hours for pain, PONV & any adverse
effects of block, if any. |
|
|
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)
|
15/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Postoperative pain after laparoscopic cholecystectomy can affect recovery and analgesic requirements. This study aims to compare the effectiveness of ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach and ultrasound-guided subcostal transversus abdominis plane (TAP) block for postoperative pain relief.
Patients undergoing elective laparoscopic cholecystectomy will be randomly allocated into two groups. Postoperative pain scores, time to first rescue analgesic, and total analgesic consumption will be assessed to identify the superior regional analgesic technique. |