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Study to compare two different types of block for post surgery pain relief after cesarean section

Phase 4
Not yet recruiting
Conditions
Pregnancy
Registration Number
CTRI/2024/04/065566
Lead Sponsor
Government medical college and hospital Chandigarh
Brief Summary

Pain following cesarean section included both somatic and visceral components and it istypically described as emanating from the abdominal wall incision. Intravenous NSAIDScombined with spinal and/or systemic opioids is usually employed for post-cesareananalgesia. Peripheral nerve blocks are the newer techniques in the multimodal analgesiaapproach and are associated with the least side effects.

Quadratus lumborum block (QLB) is one such block for postoperative analgesia in cesareanpatients. By dividing the area behind the quadratus lumborum muscle,USG QLB-2 refers to the administration of medication between the posterior side of thequadratus lumborum muscle and the medial lamina of the thoracolumbar fascia, whichseparates the posterior side of the quadratus lumborum from latissimus dorsi and the erectorspinae muscles. USG QLB-3 pertains to the administration of medication at the front of thequadratus lumborum muscle, close to the point at which it is attached to the L4 vertebra’stransverse process.

40 patients will be sampled by continuous sampling and will be allocated intogroups 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 ofPCA will be started with boluses of fentanyl with 10 micrograms per ml. The patients will beprovided with a remote controlled hand-held button and there will be a provision of patientcontrolled boluses of 1ml of 10 micrograms per ml of fentanyl, with a lockout interval of 10 minwhen needed. Inj Diclofenac 75 mg iv will be used as rescue analgesiaTime of completion of both types of USG QLB, visual analogue scale at rest (VAS-R) anddynamic VAS (VAS-D) (0, no pain; 10 worst pain imaginable) at 0, 2, 6, 12, and 24 hourspostoperatively, time for the first rescue analgesia, total number of PCA demands and totalnumber of PCA demands within 24 hours of surgery, total doses of rescue analgesia used within24 hours of surgery, apgar scores at 1 and 5 minutes and overall maternal satisfaction scoreswith nerve block (by asking the percentage of relief the patient felt on a 0-100 VAS scale) will benoted and documented

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
40
Inclusion Criteria

Age 18 to 45 years, ASA II and III patients, pregnancy beyond 34 weeks, weight < 100 kg.

Exclusion Criteria

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to first bolus of rescue analgesia postoperatively in both approaches of quadratus lumborum blockPatient assessed at 2, 4, 6, 12, 24 hours post block for pain score and rescue analgesia consumption
Secondary Outcome Measures
NameTimeMethod
Apgar scoreApgar scores at 1 minute and 5 minutes will be noted
Time of completion of both types of QLBTotal time of completion of QLB 2 and QLB 3
Assess the static and dynamic pain scores post-operativelyStatic 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 demandsAll 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 deliveredActual doses of PCA are delivered within 24 hours of the operation
Total amount of rescue analgesia consumedInj Diclofenac 75 mg iv will be used as rescue analgesia and total number of doses will be noted.

Trial Locations

Locations (1)

Government Medical college and hospital

🇮🇳

Chandigarh, CHANDIGARH, India

Government Medical college and hospital
🇮🇳Chandigarh, CHANDIGARH, India
Dr Jasmine
Principal investigator
7526839775
jasmine1singla@gmail.com

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