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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201501000965252 |
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Date of registration:
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09/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Transversus Abdominis Plane block for postoperative pain after abdominal hysterectomy in a resource poor setting: A randomised, controlled study
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Scientific title:
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EFFECT OF ADMINISTERING A BILATERAL TRANSVERSUS ABDOMINIS PLANE [TAP] BLOCK ON POSTOPERATIVE PAIN SCORES AFTER TRANS ABDOMINAL HYSTERECTOMY [TAH]: A, RANDOMISED, DOUBLE BLIND, CONTROLLED STUDY. |
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Date of first enrolment:
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20/09/2013 |
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Target sample size:
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32 |
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Recruitment status: |
Complete |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=965 |
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Study type:
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Interventional |
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Study design:
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Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,simple randomisation using coupons labelled T for study group and S for control group, random allocated and sealed in opaque envelopes,Sealed opaque envelopes
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Phase:
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Not Applicable
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Countries of recruitment
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Zimbabwe
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Contacts
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Name:
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Farai
Madzimbamuto |
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Address:
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UZCHS, Mazowe Street
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Harare
Zimbabwe |
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Telephone:
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+263779718953 |
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Email:
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faraitose@hotmail.com |
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Affiliation:
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Senior Lecturer |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: elective open trans-abdominal hysterectomy through an incision made below the level of the umbilicus.
The patients had American Society of Anesthesiologists physical status grade I-III
age between 18 to 60yrs .
Exclusion criteria: history of local anaesthetic allergy, patients receiving drugs which could result in opioid tolerance,
inability to understand study protocols, obesity BMI > 35,
weight < 40 Kg
patients who were unable or unwilling to give informed consent.
Age minimum:
18 Year(s)
Age maximum:
60 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fertility-female
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Surgery
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Surgery
Fertility-female
Postoperative pain
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Postoperative pain
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Intervention(s)
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bilateral ultrasound guided SHAM transversus
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bilateral ultrasound guided posterior Tranversus Abdominis Plane Block
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Primary Outcome(s)
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The primary outcome was the adequacy of postoperative pain relief as assessed by a Visual Analogue Scale for pain at 2hrs and 4hrs after surgery. Pain was assessed at rest and during movement.
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Secondary Outcome(s)
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patient comfort was assessed using a VAS comfort,
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total analgesic duration, noted as the time from block application to the time to first rescue analgesic request by the patient,
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Source(s) of Monetary Support
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NECTAR
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Ethics review
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Status: Approved
Approval date: 06/09/2013
Contact:
Joint Parirenyatwa Hospital And College of Health Sciences Researh Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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