Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201501000965252 Date of Approval: 09/12/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transversus Abdominis Plane block for postoperative pain after abdominal hysterectomy in a resource poor setting: A randomised, controlled study
Official scientific title 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.
Brief summary describing the background and objectives of the trial Patients suffer significant pain after major abdominal surgery.Poor pain control causes patient suffering, delayed recovery and discharge and inflates healthcare costs' Effective pain control has a humanitarian role, medical and economic benefits The current gold standard for postoperative pain control after major abdominal surgery is Patient Controlled Epidural Analgesia (PCEA) using local anesthetics in combination with narcotics. Intravenous patient controlled analgesia (IVPCA) is a good alternative method of analgesic delivery. These methods are expensive, resource consuming and labor intensive and thus not a feasible option in resource limited settings. Multimodal analgesic regimen are now advocated for, and use of regional anaesthesia blocks has a clear role. Current practice in our setting is the monomodal use of traditional intramuscular injection of pethidine or morphine. 30- 50% patients have poor pain control. A transversus abdominis plane block (TAPB)is a regional anesthetic technique with a proven efficacy. However its utility has been tested in the setting of multimodal regimen using IVPCA opioids, NSAIDS, paracetamol, and per rectal use of drugs. This study investigated the effect of adding a regional anaesthetic technique, a bilateral ultrasound-guided TAPB to the traditional intramuscular pethidine, on postoperative pain relief in patients undergoing trans-abdominal hysterectomy. 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. Secondary outcomes were: total analgesic duration, noted as the time from block application to the time to first rescue analgesic request. patient comfort was assessed using a VAS comfort, VAS bother was used to assess if patients were bothered by their surgical wounds.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Postoperative pain,Surgery
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/09/2013
Actual trial start date 20/09/2013
Anticipated date of last follow up 28/02/2013
Actual Last follow-up date 31/03/2014
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 32
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group bilateral ultrasound guided posterior Tranversus Abdominis Plane Block 20ml 0.25% bupivacaine plus 4mg dexamethasone at the end of surgery single shot administered a bilateral posterior transversus abdominis plane block under ultrasound guidance using 0.25% bupivacaine plus 4mg dexamethasone on each side 16
Control Group bilateral ultrasound guided SHAM transversus 21 mls normal saline singel shot administered a bilateral posterior 16 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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 . 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. 18 Year(s) 60 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 06/09/2013 Joint Parirenyatwa Hospital And College of Health Sciences Researh Ethics Committee
Ethics Committee Address
Street address City Postal code Country
5th Floor College of Health Sciences Building, Mazowe Street , Harare nil Zimbabwe
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. VAS pain at 2hours post TAPB administration VAS pain at 4hours post TAPB administration
Secondary Outcome total analgesic duration, noted as the time from block application to the time to first rescue analgesic request by the patient, time the patient requested for analgesia postoperatively VAS comfort at 2 hours and 4 hours post TAP block application. VAS bother at 2 hours and 4 hours post TAP block application
Secondary Outcome total analgesic duration, noted as the time from block application to the time to first rescue analgesic request by the patient, time the patient requested for analgesia postoperatively
Secondary Outcome patient comfort was assessed using a VAS comfort, VAS comfort at 2hours and 4hours post TAP block application
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Parirenyatwa Group of Hospitals Mazowe Street Harare nil Zimbabwe
FUNDING SOURCES
Name of source Street address City Postal code Country
NECTAR C FLOOR Parirenyatwa Hospital, Mazowe Street Harare nil Zimbabwe
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Nomaqhawe Moyo number 19 Baines Avenue, Harare nil Zimbabwe Commercial Sector/Industry
Secondary Sponsor NECTAR C Floor Parirenyatwa Hospital, Mazowe Street Harare nil Zimbabwe Funding Agency
COLLABORATORS
Name Street address City Postal code Country
DR Farai Madzimbamuto UZCHS Mazowe Street Harare nil Zimbabwe
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nomaqhawe Moyo nomaq79@gmail.com +263779694888 UZCHS Mazowe Street , Avondale
City Postal code Country Position/Affiliation
Harare nil Zimbabwe Postgraduate Student
Role Name Email Phone Street address
Scientific Enquiries Farai Madzimbamuto faraitose@hotmail.com +263779718953 UZCHS, Mazowe Street
City Postal code Country Position/Affiliation
Harare nil Zimbabwe Senior Lecturer
Role Name Email Phone Street address
Scientific Enquiries Samson Shumbairerwa sshumbairerwa@medsch.uz.ac.zw +263772943830 UZCHS, Mazowe Street , Avondale
City Postal code Country Position/Affiliation
Harare nil Zimbabwe Head of Department , Anaesthesia and Critical Care Medicine
REPORTING
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