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.: PACTR202210889652410 Date of Approval: 24/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Subcostal TAP Block Versus Lateral TAP Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Official scientific title Subcostal TAP Block Versus Lateral TAP Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy
Brief summary describing the background and objectives of the trial Abdominal hysterectomy is a common surgical procedure associated with considerable postoperative pain. Effective postoperative pain management reduces the incidence of postoperative complications. Many therapeutic modalities are now available for pain management with ongoing progression such as neuraxial analgesia, peripheral nerve blocks and conventional patient controlled analgesia. The objective of this study is to compare the efficacy of subcostal (anterior) and lateral TAP block for postoperative analgesia in patients undergoing total abdominal hysterectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial postoperative pain managment
Anticipated trial start date 09/10/2021
Actual trial start date 16/10/2021
Anticipated date of last follow up 08/10/2022
Actual Last follow-up date 01/11/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
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 Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group subcostal TAP Block after total abdominal hysterectomy 20 ml of 0.25% bupivacaine analgesic solution once at the end of the surgery an ultrasound device is used to demonstrate the plane between transversus abdominis muscle posteriorly and posterior rectus sheath anteriorly by placing a sterile sheathed linear probe inferior and parallel to the costal margin (subcostal approach) employing 5-15 MHz . An echogenic needle is inserted in-plane until the tip reaches the fascia between the transversus abdominis and rectus abdominis muscles. The analgesic solution of bupivacaine 0.25 % is injected after negative aspiration. 20 ml of the solution is injected on each of the right and left sides under full hemodynamics monitoring. 50
Control Group lateral TAP Block after total abdominal hysterectomy 20 ml of 0.25% bupivacaine analgesic solution once at the end of surgery While the patient is still under GA in supine position and under complete aseptic conditions, an ultrasound device is used to demonstrate the plane between transversus abdominis muscle posteriorly and internal oblique muscle anteriorly by placing a sterile sheathed linear probe at the mid axillary line midway between the subcostal margin and iliac crest (lateral approach) employing 5-15 MHz An echogenic needle is inserted in-plane until the tip reaches the fascia between the transversus abdominis and internal oblique muscles. The analgesic solution of bupivacaine 0.25 % is injected after negative aspiration. 20 ml of the solution is injected on each of the right and left sides under full hemodynamics monitoring. 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
* Patients electively scheduled for total abdominal hysterectomy * under general anesthesia * normal coagulation profile. * Refusal of the procedure or participation in the study. * Intraoperative severe bleeding and hemodynamic instability * Any history or evidence of coagulopathy * Evidence of infection at injection site * Anterior abdominal wall masses or swellings at injection site Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 75 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 04/10/2021 FMASU REC
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome control of postopertaive pain after total abdominal hysterectomy, maintenance of normal hemodynamics, reduction of narcotics use for pain and assessment of the postoperative pain by different pain scales. 1st and 2nd postoperative days every 4 hours
Secondary Outcome reduction of time needed for postoperative mobilization, reduction of hospital stay and prevention of possible postoperative cardiac and pulmonary complications due to uncontrolled pain 1st and 2nd postoperative days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University Abbasia, Cairo, Egypt Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Michael Naser Saba Abbasia Cairo 11591 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Michael Naser Saba Abbasia Cairo 11591 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Omar Mohamed Taha Abdallah ElSafty Abbasia Cairo 11591 Egypt
Randa Ali Shoukry Mohamed Abbasia Cairo 11591 Egypt
Ahmad Mohamed Mahmoud Khamis Abbasia Cairo 11591 Egypt
Engy Samy Attia Samy Abbasia Cairo 11591 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Michael Naser mikonaser39@gmail.com 01279264364 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant lecturer of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Public Enquiries Michael Naser mikonaser39@gmail.com 01279264364 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Assistant lecturer of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Omar Elsafty drosafty61@yahoo.com 01000665666 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Randa Ali randa_shoukry@hotmail.com 01001404426 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Professor of Anesthesia Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Ahmad Khamis khamisba2020@gmail.com 01222837050 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Anesthesiology Faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Engy Samy engy.sami1@yahoo.com 01276404274 Abbasia
City Postal code Country Position/Affiliation
Cairo 11591 Egypt Lecturer of Anesthesia Faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Investigators whose proposed use of the data has been approved by an independent review committee can gain access for individual participant meta-analysis
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