| CTRI Number |
CTRI/2022/09/046050 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Quadratus Lumborum block with Transverse Abdominis block in laparoscopic Gall bladder surgery for post operative pain
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Scientific Title of Study
|
Comparative evaluation of Quadratus Lumborum versus subcostal Transversus Abdominis block in laparoscopic cholecystectomy for post-operative analgesia
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Goyal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical college and associated Lok Nayak Hospital |
| Address |
Room no. 415
3rd Floor BL Taneja Block
Department of Anesthesiology
Malauna Azad Medical College
Central
DELHI
110002
India |
| Phone |
8860544175 |
| Fax |
|
| Email |
ruchigoyal403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical college and associated Lok Nayak Hospital |
| Address |
Room no. 415
3rd Floor BL Taneja Block
Department of Anesthesiology
Malauna Azad Medical College
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Goyal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical college and associated Lok Nayak Hospital |
| Address |
Room no. 415
3rd Floor BL Taneja Block
Department of Anesthesiology
Malauna Azad Medical College
Central
DELHI
110002
India |
| Phone |
8860544175 |
| Fax |
|
| Email |
ruchigoyal403@gmail.com |
|
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Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
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Primary Sponsor
|
| Name |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital,JLN Marg
New Delhi,110002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Goyal |
Lok Nayak Hospital |
Department of Anesthesiology and intensive care, BL Taneja block, Maulana Azad medical college
Lok Nayak Hospital,JLN Marg
New Delhi
DELHI |
8860544175
ruchigoyal403@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus Lumborum Block |
The Quadratus Lumborum block will be performed after induction with the patient in the lateral decubitus position by an experienced anesthesiologist. The USG probe will be placed on the anterior axillary line at the level of the umbilicus, the abdominal muscles will be visualized, and the probe will be advanced toward the posterior. After visualization of the Quadratus Lumborum muscle ,By advancing a 100 mm, 22- gauge block needle with the USG probe to be in the same plane (in-plane technique), the point between the Quadratus Lumborum muscle and the middle thoracolumbar fascia will be reached .A pre-prepared solution of 0.3ml/kg 0.25% bupivacaine (max. 20 ml) will be injected in the plane bilaterally. After completion of the Quadratus Lumborum block, surgery will commence. |
| Comparator Agent |
Subcostal Transverse Abdominis Block |
The Subcostal Transverse Abdominis block (TAP)will be performed after induction with the patient in the supine position by an experienced anesthesiologist. The USG probe will be placed on the upper abdominal wall obliquely along the subcostal edge close to the midline. After identiï¬cation of the rectus abdominis muscle (RAM), by shifting the probe obliquely along the subcostal line toward the lateral, the Transverses Abdominis muscle (TAM) will be located below the RAM. With the USG probe, a 100 mm, 22- gauge block needle will be placed between the RAM and TAM in the same plane (in-plane technique) A pre-prepared solution of 0.3ml/kg 0.25% bupivacaine (max. 20 ml) will be injected between these two muscles and will be observed to spread toward the lateral side of the RAM bilaterally. After completion of the TAP block, surgery will commence. |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.18 to 60 years of age
2.American Society of Anesthesiologists Grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Bleeding or Coagulation Abnormality
2.Local skin infection at the site of block
3.BMI>30 kg/m2
4.Allergy to study medications
5.Inability to understand Numerical Rating Scale (NRS)
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Method of Generating Random Sequence
|
Random Number Table |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Time to request for first supplemental analgesic requirement post-operatively. |
24 hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes (Heart rate and Mean arterial pressure) will be monitored and recorded before induction (baseline), after induction, post block, at skin incision and for every 15 minutes intra operatively.
2.Post-operative NRS score till 24 hours.
3.Total amount of analgesic consumption in 24 hours postoperatively.
4.Patient satisfaction score at 24 hours.
5.Block related complications, if any.
|
24 hours |
|
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Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/10/2022 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
Nil |
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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 - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - ruchigoyal403@gmail.com
- For how long will this data be available start date provided 19-09-2023 and end date provided 19-10-2024?
Response (Others) - One year
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
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Brief Summary
|
We are comparing Quadratus Lumborum Block with Subcostal Transversus Abdominis Block for post operative analgesia in patients posted for Laproscopic Cholecystectomy in Lok Nayak Hospital Delhi. A total of 80 patients with 40 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. We will be using standard general anesthesia for induction of the patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain and time for first supplemental analgesia will determined. Overall patient satisfaction score will also be assesed .
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