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Clinical Trials/CTRI/2024/03/063686
CTRI/2024/03/063686Not yet recruitingPhase 1/2

Comparison of dexamethasone vs ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section under neuraxial anesthesia

Saveetha medical college and hospital1 site in 1 country84 target enrollmentStarted: March 19, 2024Last updated:

Trial Snapshot

Phase
Phase 1/2
Status
Not yet recruiting
Sponsor
Enrollment
84
Locations
1
Primary Endpoint
Compare the analgesic efficacy of dexamethasone vs ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section surgery

Study Overview

Brief Summary

In this study, we would like to compare the analgesic efficacy ofdexamethasone and ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section under neuraxial anesthesia.

Intraoperatively, BP and PR measured at 0, 5, 10, 15 and 30 mins.

Post operatively PR and BP measured at every 20 mins for first 2 hours and at 4,6,12 and 24 hours.

Post operative VAS score in 2,4, 6,12 and 24 hours.

Patient satis Score measured after 24 hours.

Duration of onset of pain and motor power in hours.

Thank you

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • American Society of Anaesthesiologists (ASA) physical status I and II, patients undergoing lower segment caesarean section, Patient’s willingness to participate in study.

Exclusion Criteria

  • Patient’s refusal, BMI more than 35, Allergy to opioids, amide group of local anaesthetics and non steroidal anti-inflammatory drugs, Coagulation derangement or bleeding disorder, Infection at the site of block, Patients with cardiovascular pulmonary or neurological diseases, Patients converted to general anaesthesia after giving subarachnoid block, Uncontrolled intraoperative bleeding.

Outcomes

Primary Outcomes

Compare the analgesic efficacy of dexamethasone vs ketorolac as an adjutant to levobupivacaine in ultrasound guided transverse abdominis plane block for postoperative analgesia in patients undergoing lower segment caesarean section surgery

Time Frame: Post operative VAS score in 2,4,6,12 and 24 hours. | Duration of onset of pain in Hours | Duration of onset of motor power in Hours.

Secondary Outcomes

  • Post operative hemodynamics , patient satisfaction score, VAS score(Post operative Blood pressure and Heart rate at 2,4,6,12 and 24 hours.)

Investigators

Sponsor
Saveetha medical college and hospital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Suhas M

Saveetha medical college and hospital

Study Sites (1)

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