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.: PACTR201805003241310 Date of Approval: 22/03/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transversus Abdominus Plane (TAP) Block for Postoperative Analgesia After Day-Case Inguinal Hernia Repair in a Ghanaian Tertiary Hospital
Official scientific title Transversus Abdominus Plane (TAP) Block for Postoperative Analgesia After Day-Case Inguinal Hernia Repair in a Ghanaian Tertiary Hospital
Brief summary describing the background and objectives of the trial Background Inguinal hernia is a common condition whose only effective management is surgical repair. Hernia repair may be performed as an open or laparoscopic procedure and is associated with significant postoperative pain especially with open procedures. The severity of acute postoperative pain has been identified as a major predictive factor for the development of chronic pain syndromes such as chronic post-herniorrhaphy inguinal pain (CPIP). Multimodal analgesia involving techniques such as the transversus abdominis plane (TAP) block are increasingly being employed for the effective management of acute postoperative pain. OBJECTIVES 1. To compare the mean NRS scores in patients in the intervention group versus those the control group. 2. To compare the time to first analgesia in patients in the intervention group versus those in the control group. 3. To compare the degree of patient satisfaction with pain relief within the first 24 hours postoperatively in the intervention group versus control group. 4. To compare the incidence of postoperative nausea and vomiting in the intervention group versus control group. 5. To compare the total amount of opioid analgesia consumed in patients in the intervention group versus those in the control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System,INGUINAL HERNIA,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/04/2018
Actual trial start date 02/01/2019
Anticipated date of last follow up 29/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
KBTH-STC 00048/2017 SCIENTIFIC & TECHNICAL COMMITTEE KORLE BU TEACHING HOSPITAL
KBTH-IRB/00048/2017 KORLE BU TEACHING HOSPITAL INSTITUTIONAL REVIEW BOARD
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 randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Control 20mls of 0.9% saline before inguinal field block 20mls of 0.9% saline before inguinal field block 20mls of 0.9% saline 30 Placebo
Experimental Group T Group 20mls of 0.25% bupivacaine before inguinal field block JUST BEFORE INGUINAL FIELD BLOCK PRIOR TO SKIN INCISION 20ML OF 0.25% BUPIVACAINE IS USED FOR A UNILATERAL TAP BLOCK ADMINISTERED BEFORE AN INGUINAL FIELD BLOCK IS DONE WITH 20MLS OF 1% LIDOCAINE WITH ADRENALINE (1:200,000) 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. ASA I & II patients aged 18 - 70 years 2. Day-case unilateral inguinal hernia repair under local anaesthesia 1. History of allergy to amide local anaesthetics 2. Recurrent inguinal hernias 3. Incarcerated scrotal hernias 4. Obstructed inguinal hernias 5. BMI greater or equal to 35kg/m2 6. Inability to understand the NRS after thorough explanation 7. Chronic hepatic or renal failure 8. Coagulation abnormalities 9. Skin infection at the puncture site 10. Giant inguinal hernia 11. Chronic pain patients 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) 70 Year(s) Both
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 22/01/2018 Korle Bu Teaching Hospital Scientific and Technical Committee
Ethics Committee Address
Street address City Postal code Country
PO Box KB 77 Korle Bu ACCRA 11111 Ghana
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 19/06/2018 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
PO Box KB 77 Korele Bu Accra 1111 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The mean Numerical Rating Scale (NRS) score at rest at 6 hours 6 hours post-operatively
Secondary Outcome Mean NRS score at rest Immediate postop 0, 2, 4 and 24 hours
Secondary Outcome Mean NRS score on coughing/movement at 0, 2, 4, 6 and 24 hours
Secondary Outcome Degree of patient satisfaction with analgesia within the first 24 hours postoperatively as evidenced by the mean Satisfaction Assessment Score (SAS) in the intervention and the control groups jn the first 24 hours postoperatively. 24 hours postop
Secondary Outcome Time to rescue analgesia first 24 hours postop
Secondary Outcome The incidence of postoperative nausea and vomiting in those the intervention and the control groups. 24 hours postop
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KORLE BU TEACHING HOSPITAL ALEXANDER AVENUE, KORLE BU ACCRA Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Papa Kobina deGraft-Johnson COURT 2B FLAT 8, ALEXANDER AVENUE, KORLE BU ACCRA Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor KORLE BU TEACHING HOSPITAL ALEXANDER AVENUE, KORLE BU ACCRA Ghana Hospital
Primary Sponsor DR. PAPA KOBINA GYAKYE DEGRAFT-JOHNSON COURT 2B FLAT 8, ALEXANDER AVENUE, KORLE BU ACCRA Ghana Hospital
COLLABORATORS
Name Street address City Postal code Country
PROF. ERNEST ANITEYE 8 SLATER AVENUE, KORLE BU ACCRA Ghana
PROF. HENRY BADDOO ALEXANDER AVENUE, KORLE BU ACCRA Ghana
DR. ROBERT DJAGBLETEY Hse no B837/18 Ekpakpafeemo Street Accra Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator PAPA KOBINA GYAKYE DEGRAFT-JOHNSON kobby83@hotmail.com +233 24 496 3908 COURT 2B FLAT 8, ALEXANDER AVENUE, KORLE BU
City Postal code Country Position/Affiliation
ACCRA Ghana SPECIALIST ANAESTHETIST/DEPT OF ANAESTHESIA, KORLE BU TEACHING HOSPITAL
Role Name Email Phone Street address
Public Enquiries VICTOR NORTEY rdo@kbth.gov.gh +233 302 66 67 66 ALEXANDER AVENUE, KORLE BU
City Postal code Country Position/Affiliation
ACCRA Ghana IRB ADMINISTRATOR/KORLE BU TEACHING HOSPITAL
Role Name Email Phone Street address
Scientific Enquiries PAPA KOBINA GYAKYE DEGRAFT-JOHNSON kobby83@hotmail.com +233 24 496 3908 COURT 2B FLAT 8, ALEXANDER AVENUE, KORLE BU
City Postal code Country Position/Affiliation
ACCRA Ghana SPECIALIST ANAESTHETIST/DEPT OF ANAESTHESIA, KORLE BU TEACHING HOSPITAL
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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