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Clinical Trials/CTRI/2018/10/015979
CTRI/2018/10/015979Not yet recruitingPhase 4

To Compare the efficacy of Ropivacaine versus Bupivacaine during Surgical transversus Abdominis plane block for post-operative analgesia after Caesarean Section

Dr Aniket Kakade1 site in 1 country100 target enrollmentStarted: January 11, 2018Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
Outcome Name: Post operative pain relief. To be assessed by Visual Analogue score [VAS]

Study Overview

Brief Summary

This is a randomized, double blind, parallel group trial to compare the efficacy of ropivacaine versus bupivacaine during surgical transversus abdominis plane [TAP]block for post-operative analgesia after caesarean section. Surgical TAP block is a established technique used for post operative analgesia. we plan to compare two drugs in 100 patients who require caesarean section. The post operative pain will be assessed by using the visual analogue scale [VAS] and the duration of analgesia in hours after giving the drug by TAP block will be assessed. Rescue analgesia will be administered to all those patients who complain of pain at VAS 3. The secondary outcome will be study of any side effects of the drugs.

Study Design

Study Type
Interventional
Allocation
Coin toss, Lottery, toss of dice, shuffling cards etc
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 40.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • all patients who require caesarean delivery.

Exclusion Criteria

  • Patient with ASA III or above Any allergy to used drug Local infection at the site of block Patients requiring vertical abdominal incision and upper segment caesarean section Patients requiring general anesthesia Height of patient less than 150 cms and more than 180 cms (as these patients will require a different dosage of spinal anaesthesia) Patients with thrombocytopenia.

Outcomes

Primary Outcomes

Outcome Name: Post operative pain relief. To be assessed by Visual Analogue score [VAS]

Time Frame: Time Point: One hourly assessment for 8 hours

Secondary Outcomes

  • Outcome Name: Side effects of the drugs(Time Points: Every hour assessment in post operative period for 24 hours.)

Investigators

Sponsor
Dr Aniket Kakade
Sponsor Class
Other [Investigator Initiated Trial]

Study Sites (1)

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