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.: PACTR202208896910041 Date of Approval: 24/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Comparitve Study Between Ultrasound Guided versus Transperitoneal Transversus Abdominis Plane (TAP) Block For Cesarean Section Analgesia
Official scientific title A Comparitve Study Between Ultrasound Guided versus Transperitoneal Transversus Abdominis Plane (TAP) Block For Cesarean Section Analgesia
Brief summary describing the background and objectives of the trial Pain after cesarean section is usually described as moderate to severe by most patients. Pain of cesarean section essentially has two components somatic (due to abdominal wall incision) and visceral (from the uterus). A substantial component of pain experienced by patients is derived from abdominal wall incision and failure to achieve adequate treatment may affect mother-baby bonding, care of baby, and breastfeeding. It may even risk the patients for thrombo-embolism as a result of immobility due to pain. [3] Pain management should not only be adequate but also safe for the breastfeeding baby. Systemic or neuraxial opioids are the mainstay for treating postoperative pain, as they are effective against both components. However, they are associated with several undesirable side effects such as nausea, vomiting, pruritus, constipation, and respiratory depression. Nonsteroidal anti-inflammatory drugs alone may be insufficient to treat post cesarean pain.[4] Currently, multimodal analgesic technique involving abdominal nerve block with parenteral analgesics is becoming popular for these patients. Transverse abdominis plane (TAP) block is a recently introduced regional technique that blocks abdominal wall neural afferents between T6 and L1 and thus can relieve pain associated with an abdominal incision.[5] TAP is a neurovascular plane located between the internal oblique and transverse abdominis muscles and nerves supplying abdominal wall pass through this plane before supplying anterior abdominal wall. [6] Therefore, if the local anesthetic is deposited in this space, myocutaneous sensory blockade results. As postoperative pain after cesarean is predominantly due to abdominal incision, the TAP block will reduce the need of additional analgesic during 24 h after surgery, decreases severity of pain and prolong the demand for first analgesic and improve patient satisfaction during postoperative period. [7] The aim of this study is to compare between transperitoneal guided TAP block versus ultrasound guided TAP block. As regard of, duration of postoperative analgesia, patient satisfaction, the amount of additional analgesic needed for 24 hour postoperatively, duration of the procedure and complications encountered in each procedure.
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 Treatment: Other
Anticipated trial start date 14/08/2022
Actual trial start date
Anticipated date of last follow up 02/10/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 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 transperitoneal guided TAP bloc , 20 mL of 0.25% bupivacaine is introduced slowly in the TAP 24hours pierced the parietal peritoneum at the point of entry, then it is gently advanced until it pierces the transversus abdominis fascia, which is felt as a loss of resistance (“one pop”). Gentle aspiration is done to ensure that the tip of the needle is not in a blood vessel, thereafter, 15 mL of 0.25% (2.5 mg/ mL) bupivacaine is introduced slowly in the TAP, with very little resistance. 30
Control Group ultrasound guided TAP block 20 mL of 0.25% (2.5 mg/ mL) bupivacaine 24 hours A 150 mm long, 20 G short-bevel needle is introduced anteriorly and inserted in plane under real-time US guidance to lie between the internal oblique and the transversus abdominis muscles with the tip in the mid-axillary line. Gentle aspiration is done to ensure that the tip of the needle is not in a blood vessel, thereafter, 1 ml test injection of study solution is permitted to confirm needle location then 15 mL of 0.25% (2.5 mg/ mL) bupivacaine is introduced slowly in the TAP on each side. The 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Pregnant women aged 18-40 years undergoing elective cesarean section under spinal anesthesia ASA I,II Bleeding disorders and thrombocytopenia 2. obestatric complications e.g. preeclampsia. 3. Allergy to any drug will be used in the study. 4. Failed spinal block and conversion to general anesthesia 5. A history of established chronic pain 6. Drug addiction 7. A psychiatric disorder 8. Inability to communicate effectively or not willing to participate Adult: 19 Year-44 Year 18 Year(s) 40 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 07/03/2022 menoufia university faculty of medicine research ethical committee
Ethics Committee Address
Street address City Postal code Country
25- yassen abdel ghafar shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome First call for analgesia first 24 hours
Secondary Outcome Postoperative pain scores by VAS at measured points for 24 hours. 2. Total analgesic consumption 3. Patient Satisfaction whether poor, good or excellent. 4. Possible side effects as visceral injury, hematoma and local anesthetics toxicity 24hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
menofia university hospital 25- yassen abdel ghafar shebin elkom 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
noha afify 25- yassen abdei ghaffar shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine . menofia university 25- yassen abdel ghafar shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Public Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
Role Name Email Phone Street address
Scientific Enquiries noha afify nohaafify2014@gmail.com 01069113014 25- yassen abdel ghaffar
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt lecturer of anesthesia and intensive care
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). Immediately following publication, No end date Study Protocol unpredictabe unavailable
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