| CTRI Number |
CTRI/2025/02/080310 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| 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
|
EFFICACY OF QUADRATUS LUMBORUM BLOCK VERSUS TRANSVERSUS ABDOMINIS BLOCK FOR PAIN RELIEF AFTER CESAREAN DELIVERY: A RANDOMISED COMPARATIVE STUDY |
|
Scientific Title of Study
|
EFFICACY OF QUADRATUS LUMBORUM BLOCK VERSUS TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POSTOPERATIVE ANALGESIA AFTER CESAREAN SECTION: A PROSPECTIVE RANDOMISED COMPARATIVE STUDY |
| 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 Nimisha Brahambhatt |
| Designation |
Associate professor in department of anesthesiology |
| Affiliation |
medical college baroda |
| Address |
Department of anesthesiology
Medical college Baroda Anandpura Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
8160364508 |
| Fax |
8160364508 |
| Email |
nimishabrahmbhatt7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Brahambhatt |
| Designation |
Associate professor in department of anesthesiology |
| Affiliation |
medical college baroda |
| Address |
Department of anesthesiology
Medical college Baroda Anandpura Vadodara
GUJARAT
390001
India |
| Phone |
8160364508 |
| Fax |
8160364508 |
| Email |
nimishabrahmbhatt7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayushi chaudhary |
| Designation |
resident doctor of department of anesthesiology |
| Affiliation |
Baroda medical college |
| Address |
Resident doctor of department of anesthesiology Medical college Baroda Anandpura Vadodara
Vadodara
GUJARAT
390001
India |
| Phone |
7284016602 |
| Fax |
7284016602 |
| Email |
ayushi22chaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Baroda, Anandpura,Vadodara, India.390001 |
|
|
Primary Sponsor
|
| Name |
Medical college Baroda |
| Address |
Medical college Baroda,Vinoda bhave road, Anandpura, Vadodara |
| Type of Sponsor |
Government 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 Ayushi chaudhary |
SSG HOSPITAL BARODA |
1ST floor, Rukhmani chennani LROT Baroda medical college ,Vadodara ,Gujarat
Vadodara
GUJARAT |
07284016602
ayushi22chaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for biomedical and health research medical college and ssg hospital,Baroda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Quadratus lumborum block |
in this patient will be positioned in lateral decubitus position. r all aseptic and antiseptic precaution, a curvilinear low-frequency ultrasound probe will be placed transversely. Probe transitioning laterally from the umbilicus to the posterior axillary line till posterior aponeurosis of transversus abdominis muscle become visible and the lumbar interfacial triangle (LIFT) area which encapsulates the paraspinal muscle, visible between latissimus dorsi and QL muscle. The target is the deep layer of middle layer of thoracolumbar fascia (TLF). A 23-gauge quincke’s spinal needle will be inserted in-plane in anteromedial to posterolateral direction. The needle tip will be advanced and positioned between middle layer of thoracolumbar fascia and epimysium of quadratus lumborum at LIFT area. After negative aspiration, 20ml of 0.25% levobupivacaine drug will be injected in the interfascial plane posterior to the quadratus lumborum muscle, between the quadratus lumborum and the erector spinae muscles. The drug spread will be visualized ultrasonographically posterior to quadratus lumborum. Similarly QL block will be given on the other side with 20ml of 0.25% levobupivacaine. |
| Comparator Agent |
Transversus abdominis block |
Under all aseptic and antiseptic precaution, the ultrasound probe will be placed transverse to the abdomen (horizontal plane) in midaxillary line between the costal margin and the iliac crest. Three muscle layers (external oblique, internal oblique, and transversus abdominis) will be clearly seen in the image.
The needle will be inserted in- plane from anteromedial side of probe, through the adipose tissue and the external and internal oblique muscles. The tip of the needle will be placed in the superficial part of the transversus abdominis plane.
Injection of small volume of normal saline after aspiration will help guide needle tip placement. Once TAP plane will be located, the 20ml of drug (0.25% levobupivacaine ) will be injected which will be seen as a lens shaped hypoechoic area between the internal oblique and transverse abdominis muscle.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Age group of 20-40 years female posted for elective caesarean section under spinal anesthesia.
2.Normal singleton pregnancy with a gestation of at least 37 weeks.
3.ASA-II patients
4.Patient able to give verbal and informed consent.
5.Patient able to understand VAS regarding assessment of pain
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Allergy to local anaesthetics.
Patient with local site infection.
Patient with coagulopathy disorder.
Patient with uncontrolled cardiac,renal, respiratory, neurological conditions.
Any patient requiring general anesthesia at any point of time.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue analgesia (duration of analgesia in minutes) |
48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objectives:
1.To evaluate the post operative analgesia using visual analogue scale (VAS) measured at rest and on movement.
2.Total requirement of analgesic drugs in first 48 hours (in mg)
3.Hemodynamic parameters
4.Complications associated with the block.
|
48hrs |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/02/2025 |
| 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="1"
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 - NO
|
|
Brief Summary
|
The aim of the study is to compare the efficacy of ultrasound guided quadratus lumborum and transversus abdominis plane block for post operative analgesia after caesarean section. 60 patients posted for elective cesarean section were randomly selected and grouped into group Q and group T with 30 patients in each group. Primary objective is to compare the Time to first rescue analgesia (duration of analgesia in minutes) Secondary objectives is to evaluate the post operative analgesia using visual analogue scale (VAS) measured at rest and on movement., Total requirement of analgesic drugs in first 48 hours (in mg), Hemodynamic parameters, Complications associated with the block.The proposed advantage of this study is that QL provides more long duration of block and less consumption of analgesia over TAP block. |