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.: PACTR201906531856469 Date of Approval: 10/06/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Thoracic Paravertebral Block and Transversus Abdominis Plane Block for Postoperative Analgesisa in Major Gynecologic Surgery: Randomized Controlled Clinical Trial, Dilla University Referral Hospital, Dilla Town, South Ethiopia; 2018
Official scientific title Comparison of Thoracic Paravertebral Block and Transversus Abdominis Plane Block for Postoperative Analgesisa in Major Gynecologic Surgery: Randomized Controlled Clinical Trial, Dilla University Referral Hospital, Dilla Town, South Ethiopia; 2018
Brief summary describing the background and objectives of the trial Patients after major gynecologic surgeries experience moderate to severe pain, which needs pharmacological intervention. Different regional blocks are now a days introducing as components of multimodal analgesia for pain management. Even though transversus abdominis plane block and paravertebral block were described for postoperative analgesia in abdominal surgeries, data comparing these blocks for gynecologic surgery is limited. The objective of this single blind randomized controlled trail was to compare thoracic paravertebral block and transversus abdominis plane block for postoperative analgesia in patients underwent gynecologic surgery under general anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Elective gynecologic surgery
Purpose of the trial Treatment: Other
Anticipated trial start date 01/07/2018
Actual trial start date 15/09/2018
Anticipated date of last follow up 30/12/2018
Actual Last follow-up date 30/01/2019
Anticipated target sample size (number of participants) 34
Actual target sample size (number of participants) 34
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bilateral paravertebral block 15 ml of 0.25% Bupivacaine per each side The intervention given and the participants followed by out come assessors/data collectors for 24 hours. Paravertebral block was done for patients underwent gynecologic surgery with 0.25% Bupivacaine 15 ml before induction of anesthesia in sitting position. 17
Control Group transversus abdominis plane block 15 ml of 0.25% Bupivacaine patients after surgery were followed by the outcome assessor/data collectors for 24 hours. Transversus abdominis plane block was done with 0.25% Bupivacaine in supine position bilaterally as control. 17 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Age 18-65 ASA physical status I and II Patients with BMI greater than 30kg/m2 History of substance abuse Chronic use of medications (both opioids and non-opioids) Patients who took analgesia or sedative drugs within 24 hours before the study History of allergy to LA Local infection at site of application of the block Anatomical deformity of the respected vertebra for PVB Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 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 04/09/2018 Dilla University College of Health Sciences and Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Dilla University, Dilla Town Dilla 1000419 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to first analgesic request its measured at the time when the patient requests analgesia at postop period
Secondary Outcome NRS score Total analgesic consumption these outcomes measured at 0, 2, 4, 6, 12, and 24 hours postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla University Referral Hopsital Dilla Town, Gedeo Zone, SNNPR, south Ethiopia Dilla Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Dilla University Dilla Town, Gedeo Zone, SNNPR, South Ethiopia Dilla Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dilla University Dilla Town, Gedeo Zone, SNNPR, South Ethiopia Dilla Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Nugusu Ayalew Dilla Town, Gedeo Zone, SNNPR, Southern Ethiopia Dilla 1000419 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Siraj Ahmed srjmyn@gmail.com +251912282596 Dilla University, Dilla Town
City Postal code Country Position/Affiliation
Dilla Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries Nugusu Ayalew nugusu.ayalew@gmail.com +251911003318 Dilla Univewrsity, Dilla Town
City Postal code Country Position/Affiliation
Dilla Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries Tizalegn Tesfaye ttizetesfaye@gmail.com +251910894884 Dilla Town, Gedeo Zonee
City Postal code Country Position/Affiliation
Dilla Ethiopia Lecturer and Head of school of public Heath
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study participants are patients scheduled for elective gynecologic surgery whom randomly selected and randomly allocated in two groups Informed Consent Form,Statistical Analysis Plan,Study Protocol with in 6 months of completion of the study. Access for IPD is strictly controlled for the safety of study participants confidentiality. for reviewers and editors for publication and other related issues access may be via contact of principal investigator as needed.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information