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CTRI Number  CTRI/2026/02/104638 [Registered on: 24/02/2026] Trial Registered Prospectively
Last Modified On: 20/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of efficacy of modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostal transversus abdominis plane block for postoperative pain management. 
Scientific Title of Study   To compare efficacy of modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostal transversus abdominis plane block for postoperative pain management. 
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 Richa Jain 
Designation  Associate Professor, Department of Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia,Dayanand Medical College and Hospital,Tagore Nagar,Civil Lines,Ludhiana 141001 Punjab

Ludhiana
PUNJAB
141001
India 
Phone  9815068242  
Fax    
Email  richajain2105@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kulmeet Kaur 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  7009343427  
Fax    
Email  meetmakkar893@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kulmeet Kaur 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana

Ludhiana
PUNJAB
141001
India 
Phone  7009343427  
Fax    
Email  meetmakkar893@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical College and Hospital,Tagore Nagar,Civil Lines,Ludhiana PUNJAB 141001 India 
 
Primary Sponsor  
Name  Dayanand Medical College and Hospital 
Address  Tagore Nagar, Civil Lines, Ludhiana 141001, Punjab, India 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Richa Jain  Dayanand Medical College and Hospital  Department of Anaesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana 141001 Punjab India
Ludhiana
PUNJAB 		 9815068242

richajain2105@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical Committee, Dayanand Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP M: Patients who will receive M-TAPA block using 25ml of 0.2 percent ropivacaine.  The operator performing the block will stand on the patient’s right side, with the patient positioned supine. A high- frequency (6-13MHz) linear ultrasound probe (SonoSite Edge 2) will be placed in the sagittal direction on the 10th costal margin and the three different layers of abdominal wall – external oblique, internal oblique and transversus abdominis muscles will be identified. A 100mm ,20-Gauge stimuplex needle (Stimuplex Ultra 360; B. Braun Melsungen AG 34209 Melsungen, Germany) will be inserted using the in-plane technique in the caudo-cranial direction till the needle tip is placed between the transversus abdominis muscle and the lower surface of the 10th costal cartilage. After confirming negative aspiration for blood, 25ml of 0.2 percent ropivacaine will be administered per side under the lower surface of the chondrium. 
Comparator Agent  GROUP O: Patients who will receive OSTAP block using 25 ml of 0.2 percent ropivacaine.  The operator performing the block will stand on the patient’s left side, with the patient positioned supine. A high- frequency (6-13MHz) linear ultrasound probe (SonoSite Edge 2) will be placed along the subcostal margin of the upper abdominal wall and the rectus abdominis and the underlying transversus abdominis muscles will be identified near the costal margin and xiphoid area. A 100mm, 20-Gauge stimuplex needle (Stimuplex Ultra 360; B. Braun Melsungen AG 34209 Melsungen, Germany) needle will be inserted using the in-plane technique between rectus abdominis and transversus abdominis fascia. Local anaesthetic will be incrementally administered into the transversus abdominis plane (TAP) using hydrodissection, with the needle following the oblique subcostal line (from xiphoid process to the iliac crest). Initially, 1 to 2 mL of local anaesthetic will be injected between the rectus abdominis and transversus abdominis muscles to confirm proper needle tip positioning. After confirming negative aspiration for blood, a total of 25ml of 0.2% ropivacaine will be delivered per side along the oblique subcostal line. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. Female patients aged 18 to 70 years scheduled for total laparoscopic hysterectomy under general anaesthesia
2. ASA I-III

 
 
ExclusionCriteria 
Details  1. Presence of any coagulation disorder
2. Chronic opioid, alcohol or any drug abuse
3. Block injection site infection
4. Refusal to participate
5. Pregnancy
6. Allergic to local anaesthetics
7. Pre-existing cognitive dysfunction
8. BMI more than or equal to 40 kg/m² 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total amount of tramadol consumed by the patient in first 24 hours postoperatively.  Total amount of tramadol consumed by the patient in first 24 hours postoperatively. 
 
Secondary Outcome  
Outcome  TimePoints 
1. NRS pain scores at rest & on movement.
2. Time of need for first rescue opioid analgesic.
3. Quality of patient recovery-15 score at 24 hours postoperatively.
4. Patient satisfaction using likert scale at 24 hours. 		 Quality of patient recovery-15 score & patient satisfaction using likert scale at 24 hours postoperatively.
NRS at 0,1,2,4,8,12 & 24 hours postoperatively. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   03/03/2026 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  Thesis publication

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Total laparoscopic hysterectomy (TLH), though a minimally invasive gynaecological procedure, is frequently associated with significant postoperative pain,particularly within the first 24–48 hours. Pain after TLH is multifactorial, involving somatic pain from trocar insertion, visceral pain from uterine and pelvic manipulation, and referred shoulder pain from diaphragmatic irritation caused by pneumoperitoneum.Effective management of this pain is important not only for patient comfort but also to facilitate early ambulation, reduce hospital stay, and lower the risk of complications such as thromboembolism and chronic postoperative pain.

Although opioid-based treatments are traditionally effective, their undesirable side effects such as nausea, vomiting, respiratory depression, sedation, pruritus, constipation, ileus, opioid dependency, etc. can interfere with recovery and extend hospital stays.In recent years, newer blocks such as oblique subcostal transversus abdominis plane block (OSTAP) and modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) have been found to effectively cover T6-L1 and T7-T12 dermatomal regions respectively, making them suitable options for pain control in laparoscopic gynaecological surgeries. 

Therefore, this study is needed to evaluate and compare the analgesic efficacy of the M-TAPA and OSTAP blocks as part of a multimodal analgesia approach for pain management in patients undergoing total laparoscopic hysterectomy.
 
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