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.: PACTR202303539794048 Date of Approval: 03/03/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A randomized double-blinded clinical trial to investigate the role of ultrasound-guided transversus abdominis plane block
Official scientific title A randomized double-blinded clinical trial to investigate the role of ultrasound-guided transversus abdominis plane block after a radical hysterectomy of cervical cancer
Brief summary describing the background and objectives of the trial The conventional treatment for pain control after laparotomy still involves narcotics. Sadly, opioids have several adverse side effects, such as nausea and a slow return of bowel function. However, Epidural and spinal anesthesias are widely used in postoperative pain management to minimize these adverse effects. Due to a lack of literature in this field, it is currently unknown whether these findings apply to the gynecologic oncology population. We hypothesize that patients who receive multimodal analgesia with patient-controlled anesthesia devices and TAP blocks will experience improved pain quality, resulting in decreased intravenous narcotic use, reduced length of stay, and improved bowel function, in contrast to conventional postoperative pain management with patient-controlled analgesia devices. Therefore, this study aims to determine if an ultrasound-guided transversus abdominis plane (TAP) block can decrease postoperative opioid consumption and enhance outcomes in individuals having cervical cancer surgery with a radical hysterectomy procedure. The results of this study will advance our understanding of the ideal analgesic regimen for patients undergoing cervical cancer surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TAP
Disease(s) or condition(s) being studied Anaesthesia,Cancer,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2023
Actual trial start date 02/07/2023
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date 01/10/2023
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 50
Recruitment status Closed to recruitment,follow-up continuing
Publication URL https://www.bmj.com
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 randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TAP block with bupivacaine 20 ml of 0.25 % bupivacaine will be given for cases (TAP block) at the end of the surgery 10 minutes At the end of the operation, the block will be injected into the anterior abdominal wall. The TAP block will be placed using the usual procedure at the anterior axillary line, halfway between the subcostal border and the iliac crest. A 23-gauge spinal needle will be used, and there will be a total of bilateral injection sites. The transversus abdominis muscles will be shown to be lateral to the semilunar line using ultrasound imaging. There will be two equal portions of the bupivacaine to be injected. Once two "pops" are felt, the needle penetrates the two fascial layers. The needle was withdrawn by roughly 3 mm when the tip could be seen just above the peritoneum, placing the end of the instrument just above the delicate transversus abdominis muscle. The solution could now access the spinal nerves because the needle will be in the plane between the internal oblique and transversus abdominis muscles. The procedure will be repeated twice in the TAP (20 mL each). 50
Control Group TAP block 20 ml saline 10 minutes placebo with normal saline 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adults aged greater than 18 years old with the following criteria will be considered. • Patients with the classification of ASA physical status II and III • Patients who can tolerate a general anesthetic • Patients undergoing cervical cancer surgery (radical hysterectomy) under general anesthesia, • Patients who can provide informed consent for the surgery • 20 ml of 0.25 % bupivacaine will be given for cases (TAP block) at the end of the surgery • Patients' weights are between 40-80 kg. • Patients who can provide informed consent for the surgery • Patients who have bleeding disorders • Patients who are GCS <15 • Communication failure • Patients who have an allergy to local anesthetics • Patients who have multiple site surgery (outside of abdomen) • Patients who have underlying cardiovascular diseases • Patients with chronic pain and opioid use (using oral morphine greater than 100 mg daily). Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 27/02/2023 Bahir Dar University College of Medicine Health Sciences
Ethics Committee Address
Street address City Postal code Country
Amhara Region Bahir Dar 00079 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary endpoint is postoperative pain which a numerical rating scale will assess After surgical intervention
Secondary Outcome Total postoperative analgesic consumption: the total amount of analgesic requirement within the given postoperative period Time for first-time analgesic request: the initial time in which the patient feels pain and asks for analgesia Complications: any adverse events reported after surgery post surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tibebe Ghion Specialized Hospital Bahir Dar University Amhara region Bahir Dar 00079 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Fantahun Tarekegn Amhara region Bahir Dar 0079 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Bahir Dar University Amahara Region Bahir Dar 0079 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Eyaya Misgan Amhara region Bahir Dar 00079 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Fantahun Tarekegn Kumie medeset39@gmail.com +251913824072 Amhara Region
City Postal code Country Position/Affiliation
Bahir Dar 0079 Ethiopia Assistant Professor at Bahir Dar University
Role Name Email Phone Street address
Public Enquiries Eyaya Misgan eyayamisgan@gmail.com +251913093115 Amhara Region
City Postal code Country Position/Affiliation
Bahir Dar 0079 Ethiopia associate professor
Role Name Email Phone Street address
Scientific Enquiries Amanuel Sisay Endeshaw yelfgntamirat@gmail.com +251911412266 Amhara Region
City Postal code Country Position/Affiliation
Bahir Dar 0079 Ethiopia Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data Sharing Statements that Fulfill the ICMJE Requirements o Will individual participant data be available (including data dictionaries)?Yes o What data, in particular, will be shared? All of the individual participant data collected during the trial, after deidentification. o What other documents will be available? Study Protocol, Statistical Analysis Plan, Informed Consent Form, Clinical Study Report, Analytic Code o When will data be available (start and end dates)? Immediately following publication. No end date o With whom? Anyone who wishes to access the data. o For what types of analyses? Any purpose. o By what mechanism will data be made available? Data are available indefinitely at (https://www.bmj.com/content). Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date Anyone who wishes to access the data.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Data are available indefinitely at https://www.bmj.com/content). 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