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Clinical Trials/CTRI/2021/07/035203
CTRI/2021/07/035203Not yet recruitingPhase 2/3

Comparison of burprenorphine and morphine an adjuvant to 0.25% bupivacaine for post operative analgesia with ultrasound guided transversus abdominal plane block in cesarean delivery.

M MUGUNDA RAJ1 site in 1 country70 target enrollmentStarted: August 30, 2021Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
70
Locations
1
Primary Endpoint
Heart rate,

Study Overview

Brief Summary

Post operative pain in cesarean delivery is of utmost concern, inadequate pain relief may lead to Poor recovery and prolong hospital stay. Hence it require a multimodal approach, as transversus abdominis plane has extended course of subcostal, ilioinguinal, iliohypogatric and genitofemoral nerves.A transversus abdominis plane (TAP) block is more appropriate in lower abdominal surgeries.As blind injections can result in inadvertent injury to bowel or blood vessels using ultrasound guided transversus abdominis plane block is more is more appropriate. Bupivacaine has shown its efficacy in providing post operative analgesia for 6 to 8hours adding an adjuvant will prolong its effect.In this study we are about to compare the post operative analgesic effect of buprenorphine and morphine when added as adjuvant to 0.25% bupivacaine in ultrasound guided transversus abdominis plane block, in patient undergoing cesarean delivery.

Study Design

Study Type
Interventional
Allocation
Stratified block randomization
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patient with ASA physical status-2 posted for cesarean delivery.

Exclusion Criteria

  • Chronic pain disorder
  • Known allergy or hypersensitivity to the study drug
  • Coagulopathy 4.local infection at block site 5.patient refusal for the procedure.

Outcomes

Primary Outcomes

Heart rate,

Time Frame: All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours.

Post operative pain assessment (VAS score),

Time Frame: All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours.

Respiratory rate,

Time Frame: All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours.

Blood pressure,

Time Frame: All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours.

Oxygen saturation.

Time Frame: All these parameters are measured every 15mins for 1st hour,then every hourly upto 12hours,Then every 4th hourly upto 24hours.

Secondary Outcomes

  • 24 hour analgesic consumption, nausea, vomiting, pruritis,(Monitored for 24 hours)

Investigators

Sponsor
M MUGUNDA RAJ
Sponsor Class
Other [self]

Study Sites (1)

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