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Clinical Trials/CTRI/2011/12/002267
CTRI/2011/12/002267RecruitingNot Applicable

Efficacy of ultrasound guided transversus abdominis plane block after laparoscopic bariatric surgery : adouble blind,randomised ,controlled study

Max Super Speciality Hospital1 site in 1 country100 target enrollmentStarted: March 8, 2009Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100
Locations
1
Primary Endpoint
Requirement of Tramazac hydrochloride in first 24 hours after surgery

Study Overview

Brief Summary

Aims and Objectivesxml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /

General anaesthesia in morbidly obese is associated with risk of multiple cardiopulmonary complications. These can be further aggravated with sedation, immobilization and hypoventilation from administration of narcotic analgesics in the postoperative period . We wished to study the analgesic potential of TAP block which produces dermatosensory block of the lower six thoracic and upper lumbar abdominal afferents , in this vulnerable group of patients .We believe this group of patients would benefit from opioid sparing effect of this block. In our literature search we did not come across any study which has evaluated the possible benefits of this block in this patient population.

Hypothesis

We hypothesised that use of ultrasound guided TAP (USG TAP) block as a part of multimodal analgesia will minimise postoperative opioid requirement, expedite ambulation and minimise adverse events in morbidly obese patients undergoing laparoscopic gastric bypass under general anaesthesia.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • •BMI> 35 Kg/m2 Either Gender Posted for Laparoscopic bariatric surgery Under general anaesthesia.

Exclusion Criteria

  • •1.Any relevant drug allergy 2.Seizure disorder 3.Antidepressants.

Outcomes

Primary Outcomes

Requirement of Tramazac hydrochloride in first 24 hours after surgery

Time Frame: Requirement of Tramazac hydrochloride in first 24 hours after surgery

Secondary Outcomes

  • : VAS score, RASS ((Richmond Agitation - Sedation Scale; table 1), time to ambulate, adverse events(First 24 hours from end of surgery)

Investigators

Sponsor Class
Research institution and hospital

Study Sites (1)

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