CTRI Number |
CTRI/2024/04/065566 [Registered on: 12/04/2024] Trial Registered Prospectively |
Last Modified On: |
10/04/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study to compare two different types of block for post surgery pain relief after cesarean section |
Scientific Title of Study
|
Comparison of postoperative analgesia for patients undergoing cesarean section with ultrasound-guided quadratus lumborum block-2 vs quadratus lumborum block-3 |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
GMCH/IEC/2023/257 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Jasmine |
Designation |
Postgraduate |
Affiliation |
Government medical college and hospital Chandigarh |
Address |
Department of Anaesthesiology and Critical care
Fifth Floor D-block Government medical college and hospital Chandigarh
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
7526839775 |
Fax |
|
Email |
jasmine1singla@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sukanya Mitra |
Designation |
Professor |
Affiliation |
Government medical college and hospital Chandigarh |
Address |
Department of Anaesthesiology and Critical care
Fifth Floor D-block Government medical college and hospital Chandigarh
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
9646121521 |
Fax |
|
Email |
drsmitra12@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sukanya Mitra |
Designation |
Professor |
Affiliation |
Government medical college and hospital Chandigarh |
Address |
Department of Anaesthesiology and Critical care
Fifth Floor D-block Government medical college and hospital Chandigarh
160030
India
Chandigarh CHANDIGARH 160030 India |
Phone |
9646121521 |
Fax |
|
Email |
drsmitra12@yahoo.com |
|
Source of Monetary or Material Support
|
Government medical college and hospital,Chandigarh, India 160030 |
|
Primary Sponsor
|
Name |
Government medical college and hospital Chandigarh |
Address |
fifth floor D block Government Medical college and hospital Chandigarh 160030 |
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 Jasmine |
Government Medical college and hospital |
Gynaecology Operation theater A block level 3, Area 35, Department of Gynaecology Chandigarh CHANDIGARH |
7526839775
jasmine1singla@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of Government Medical college and hospital Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Pregnancy |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Quadratus lumborum block Type 2 |
Quadratus lumborum block Type 2 will be given at the end of cesarean section with 0.3 ml/kg of 0.25 % bupivacaine bilaterally in Group 1 patients and observed for 24 hours |
Comparator Agent |
Quadratus lumborum block Type 3 |
Quadratus lumborum block Type 3 will be given at the end of cesarean section with 0.3 ml/kg of 0.25 % bupivacaine bilaterally in Group 2 patients and observed for 24 hours |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
45.00 Year(s) |
Gender |
Female |
Details |
Age 18 to 45 years, ASA II and III patients, pregnancy beyond 34 weeks, weight < 100 kg |
|
ExclusionCriteria |
Details |
Allergy to local anesthetic drugs,obstetric complications (premature rupture of amniotic membranes, premature labor, eclampsia, antepartum hemorrhage, chorioamnionitis, HELLP syndrome), severe systemic diseases, coagulation abnormalities, patients with history of immunosuppression, Patients having intraoperative adverse events like hemorrhage, thromboembolism, bradycardia, allergic reaction etc., weight > 100 kg |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Time to first bolus of rescue analgesia postoperatively in both approaches of quadratus lumborum block |
Patient assessed at 2, 4, 6, 12, 24 hours post block for pain score and rescue analgesia consumption |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assess the static and dynamic pain scores post-operatively |
Static and dynamic pain scores will be assessed post-operatively for 24 hours at regular time intervals by asking the patient to flex their legs and by turning to one side |
Total number of PCA demands |
All the patients will receive PCA infusion maintained with boluses of fentanyl with 10 micrograms per ml. The patients will be provided with a remote controlled hand-held button and there will be a provision of patient controlled boluses of 1ml of 10 micrograms per ml of fentanyl, with a lockout interval of 10 min when needed. Total number of PCA demands will be noted |
No of PCA doses delivered |
Actual doses of PCA are delivered within 24 hours of the operation |
Total amount of rescue analgesia consumed |
Inj Diclofenac 75 mg iv will be used as rescue analgesia and total number of doses will be noted. |
Apgar score |
Apgar scores at 1 minute and 5 minutes will be noted |
Time of completion of both types of QLB |
Total time of completion of QLB 2 and QLB 3 |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
21/04/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
21/04/2024 |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" 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 - NO
|
Brief Summary
|
Pain following cesarean section included both somatic and visceral components and it is
typically described as emanating from the abdominal wall incision. Intravenous NSAIDS
combined with spinal and/or systemic opioids is usually employed for post-cesarean
analgesia. Peripheral nerve blocks are the newer techniques in the multimodal analgesia
approach and are associated with the least side effects. Quadratus lumborum block (QLB) is one such block for postoperative analgesia in cesarean
patients. By dividing the area behind the quadratus lumborum muscle,
USG QLB-2 refers to the administration of medication between the posterior side of the
quadratus lumborum muscle and the medial lamina of the thoracolumbar fascia, which
separates the posterior side of the quadratus lumborum from latissimus dorsi and the erector
spinae muscles. USG QLB-3 pertains to the administration of medication at the front of the
quadratus lumborum muscle, close to the point at which it is attached to the L4 vertebra’s
transverse process. 40 patients will be sampled by continuous sampling and will be allocated into
groups by randomisation. GROUP 1 (n = 20): This group will receive USG QLB-2 GROUP 2 (n = 20): This group will receive USG QLB-3 All the patients will receive PCA infusion after positioning the patient supine. Maintenance of
PCA will be started with boluses of fentanyl with 10 micrograms per ml. The patients will be
provided with a remote controlled hand-held button and there will be a provision of patient
controlled boluses of 1ml of 10 micrograms per ml of fentanyl, with a lockout interval of 10 min
when needed. Inj Diclofenac 75 mg iv will be used as rescue analgesia
Time of completion of both types of USG QLB, visual analogue scale at rest (VAS-R) and
dynamic VAS (VAS-D) (0, no pain; 10 worst pain imaginable) at 0, 2, 6, 12, and 24 hours
postoperatively, time for the first rescue analgesia, total number of PCA demands and total
number of PCA demands within 24 hours of surgery, total doses of rescue analgesia used within
24 hours of surgery, apgar scores at 1 and 5 minutes and overall maternal satisfaction scores
with nerve block (by asking the percentage of relief the patient felt on a 0-100 VAS scale) will be
noted and documented
|