| CTRI Number |
CTRI/2024/10/075972 [Registered on: 28/10/2024] Trial Registered Prospectively |
| Last Modified On: |
26/10/2024 |
| 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
|
A clinical trial to compare two techniques of pain relief using two blocks for abdominal surgery in adults |
|
Scientific Title of Study
|
Comparison of ultrasound guided modified thoracoabdominal block through perichondrial approach M TAPA with external oblique plane block EXOP versus M TAPA in laparoscopic cholecystectomy a prospective randomized double blinded study |
| Trial Acronym |
M TAPA
EXOP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bikash Ranjan Ray |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5012
Anaesthesiology office,
Department of Anaesthesiology,Pain medicine ans Critical care,
5th floor,Academic block,
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
98899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bikash Ranjan Ray |
| Designation |
Additional Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 5012
Anaesthesiology office,
Department of Anaesthesiology,Pain medicine ans Critical care,
5th floor,Academic block,
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
98899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sijo Javad |
| Designation |
Junior Resident |
| Affiliation |
AIIMS New Delhi |
| Address |
Room number 5011,
Anaesthesiology office,
Department of Anaesthesiology,Pain medicine ans Critical care,
5th floor,Academic block,
AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
9746677494 |
| Fax |
|
| Email |
drsijojavad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, Pain medicine and Critical care,AIIMS New Delhi, Ansari Nagar,New Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, New Delhi
Ansari Nagar
110029 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Bikash Ranjan Ray |
AIIMS New Delhi |
AB8
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS, New Delhi
South
DELHI |
9899323110
bikashray.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
General Anaesthesia only |
General anesthesia will be induced with fentanyl (2mcg/kg) and propofol (2mg/kg). Tracheal intubation will be facilitated by a bolus administration of atracurium(0.5mg/kg). Maintenance of anesthesia will be done with isoflurane and 50% O2 in air to target a MAC of 0.8-1.0. Muscle relaxation will be maintained with incriminatory dose of Atracurium (0.1mg/kg).After the surgery, patient will be followed up at regular intervals for 24hrs post surgery for pain assessment and management
|
| Intervention |
Thoracoabdominal Block Through Perichondrial Approach (M-TAPA) |
The patient will be placed in a supine position, and the bed height will be adjusted so that the ultrasound system screen can be viewed with minimal head movement. After tracheal intubation and before the surgical procedure, the transversus abdominis, internal oblique, and external oblique muscles were identified using a high-frequency (12 MHz) linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. This process was repeated for the other side.The probe was slightly pushed towards the costochondral angle to view the i.nferior aspect of the chondrium. After obtaining the desired image, a 22G, 80 mm echogenic block needle was advanced in the inferolateralâ€superomedial direction with the inâ€plane technique. After reaching the lower part of the chondrium, it was noted that the needle tip never crossed the cranial edge of the 10th costal cartilage, and 20 mL of 0.25% ropivacaine was injected into the lower surface of the chondrium following negative aspiration. The same process was repeated for the other side.After the block, patient will be followed up at regular intervals for 24hrs post surgery for pain assessment and management
|
| Intervention |
Thoracoabdominal Block Through Perichondrial Approach (M-TAPA) with External Oblique Plane Block (EXOP) |
M-TAPA BLOCK:
Patient will be placed in supine position, and the bed height will be adjusted so that position, the ultrasound system screen can all be viewed in direct line of site with minimal head movement. Following the tracheal intubation and before the surgical procedure, transversus abdominis, internal oblique, and external oblique muscles were identified with a high-frequency (12 MHz) linear probe on the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal margin. The same process was repeated for the other side.The probe was slightly pushed towards the costochondral angle to view the inferior aspect of the chondrium. After obtaining desired image and a 22G, 80 mm echogenic block needle is advanced in the inferolateralâ€superomedial direction with the inâ€plane technique. After reaching the lower part of the chondrium, it was noted that the needle tip never crossed the cranial edge of the 10th costal cartilage and 20 mL of 0.25% ropivacaine was injected into the lower surface of the chondrium following negative aspiration. The same process is repeated for the other side.
EXOP:Patient will be in supine position, and the bed height will be adjusted so that position, the ultrasound system screen can all be viewed in direct line of site with minimal head movement. Under aseptic conditions, an ultrasound (US) probe with a linear frequency range of 5–10 MHz is inserted towards the costochondral angle in the sagittal plane and a needle is introduced using the in-plane technique. The needle tip is moved to the anterior aspect of the 10th costal cartilage, the plane superficial to the external oblique muscle for the costal EXOP injection is identified. After negative aspiration for blood,15ml of 0.25% ropivacaine is administered for each injection. After the block , patient will be followed up at regular intervals for 24hrs post surgery for pain assessment and management
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing laparoscopic cholecystectomy
2. ASA I-II
|
|
| ExclusionCriteria |
| Details |
a. Refusal of consent
b. Contraindications of Nerve Block
c. Chronic opioid or analgesic use
d. Allergic to study medications
e. Bleeding disorders
f. Anatomical deformity
g. Infection at block site
h. History of abdominal surgery
i. Advanced liver or kidney failure
j. Conversion to open surgery |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessed by NRS score at 0,1,2,4,6,12,24 hours after surgery. |
Pain assessed by NRS score at 0,1,2,4,6,12,24 hours after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of usage of first rescue analgesia
2.Cumulative opioid requirement in both the group
3.Total block performance time |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
11/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
11/11/2024 |
| 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 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bikashray.aiims@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2029?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Laparoscopic Cholecystectomy has beneficial
effects such as requiring a minimal surgical incision,
shortening the hospital stay and minimising postâ€operative
pain. Conventionally regional anaesthesia techniques like
OBLIQUE SUBCOASTAL TRANSVERSUS
ABDOMINIS PLANE BLOCK (OSTAP), SERRATUS
INTERCOASTAL PLANE BLOCK (SIP)is used for
supraumbilical surgeries.
Administration of a modified thoracoabdominal
nerve block through a perichondrial approach (Mâ€TAPA)
has recently been identified as a technique providing
effective analgesia on the anterior and lateral
thoracoabdominal wall. It has been reported that the T5â€
T12 thoracoabdominal nerves are blocked with this method
and that it can be used as a suitable block in laparoscopic
upper abdominal surgeries. In adults, however in some
studies the analgesic effect provided by M-TAPA to lateral
abdominal was less effective.
EXTERNAL OBLIQUE MUSCLE PLANE
BLOCK is a technique that is found to be effective for
lateral abdominal wall analgesia. Some studies shows that it
may be anatomically plausible for the combined use of
these blocks to anaesthetise the entire abdominal wall.
Hence, we aim to compare the post operative pain scores of
patients undergoing lap cholecystectomy who receives M-
TAPA in combination with EXTERNAL OBLIQUE
MUSCLE PLANE BLOCK v/s patients who receives only
M-TAPA with a control group. |