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Clinical Trials/NCT01144273
NCT01144273UnknownNot Applicable

Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial

United Christian Hospital1 site in 1 country50 target enrollmentStarted: May 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
postoperative 24hr morphine consumption

Study Overview

Brief Summary

Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.

Detailed Description

Potential advantages compared to percutaneous approach are decrease in risk of visceral injury as it is under direct visual and tactile guidance, ease of approach in obese patients, short theatre time for administration, easy to administer.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • ASA physical status I-III
  • Age 18 or above
  • Scheduled to undergo TAH+/- salpingoophorectomy.
  • Scheduled to receive general anaesthesia under standardized anaesthetic regime.
  • Comprehends how to use intravenous patient controlled analgesia (IV PCA).
  • Is willing to complete the postoperative assessment.
  • Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.

Exclusion Criteria

  • Known allergy to drugs involved in this study
  • Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
  • Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
  • With co-existing pathology resulting in persistent pain requiring analgesics.
  • Wound incision extending to supra-umbilical level.

Outcomes

Primary Outcomes

postoperative 24hr morphine consumption

Time Frame: 24 hours

The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.

Secondary Outcomes

  • morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.(24hrs)
  • Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough(24hrs)
  • incidence of nausea and vomiting(24hours postoperatively)

Investigators

Sponsor Class
Other

Study Sites (1)

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