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.: PACTR202203777048100 Date of Approval: 28/03/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Transversus Abdominis Plane Block Combined with peritoneal block versus Transversus Abdominis Plane Block alone after cesarean section
Official scientific title Transversus Abdominis Plane Block Combined with peritoneal block versus Transversus Abdominis Plane Block alone for postoperative analgesia after cesarean section: A prospective randomized controlled double-blinded study
Brief summary describing the background and objectives of the trial Cesarean section (CS) is an important lifesaving operation for both mother and child, and its use has increased dramatically over the last decade. The cesarean section rate continues to increase in many parts of the world for both medical indications and maternal choice. Postoperative pain relief after elective cesarean delivery is challenging because it needs to provide maternal satisfaction while having no adverse effects on the baby. Various techniques have been used for postoperative pain relief after cesarean delivery under spinal anesthesia, including intrathecal and/or systemic opioids, abdominal nerve blocks, and truncal blocks such as the transversus abdominis plane (TAP) block with parenteral analgesics and bilateral erector spinae plane (ESP) block. Transversus Abdominis Plane Block is an effective analgesic technique in mothers undergoing cesarean delivery and works by blocking the anterior rami of the spinal nerves of the abdominal anterior wall between T6 and L1 and thus can relieve pain after spreading of the local anesthetic agent in the neurofascial plane between the internal oblique and transversus abdominis muscle, thereby relieving the pain of cesarean section. pain after cesarean section essentially has two components somatic (due to abdominal wall incision) and visceral (from the uterus). Predominant somatic pain is very well-relieved by TAP block. However, the visceral part could be irritating for some patients with a low pain threshold. Preliminary reports suggested that infusing local anesthetics in the intraperitoneal space will cause a reversible interruption of nerve impulse conduction, resulting in blocking of visceral afferent signaling. This can potentially modify visceral nociception and downstream illness responses, thus minimizing the perception of pain
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: Surgery
Anticipated trial start date 15/04/2022
Actual trial start date
Anticipated date of last follow up 15/08/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group cases with no block performed once patients will be subjected to neither transversus abdominis plane block nor peritoneal block. 60 Placebo
Experimental Group Transversus Abdominis Plane Block once patients will be subjected to .20 ml 0.25% bupivacaine to perform transversus abdominis plane block alone. The block will be performed bilaterally 60
Experimental Group Transversus Abdominis Plane Block combined with peritoneal block. once patients will be subjected to 20 ml 0.25% bupivacaine to performTransversus Abdominis Plane Block on each side combined with intraperitoneal instillation of 20 ml bupivacaine 0.25% prepared by adding 10 ml of sterile saline solution 0.9% to 10 ml of 0.5% bupivacaine to perform peritoneal block 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Pregnant ladies aged between 18 and 40 years. • Singleton full-term pregnancy. • Pregnant ladies prepared for elective cesarean section. • American society of anesthesiologists class II or III. • Age beyond the previously mentioned ranges. • Emergency cesarean section. • Twin pregnancy. • ASA class > III. • BMI > 40 kg/m2. • Blood coagulation pathologies. • Known allergy to study medications. • Having any contraindications for spinal anesthesia. Adolescent: 13 Year-18 Year,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 06/11/2021 Research Ethics Committee of Faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El Geish Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to the first analgesic request after the operation immediately post operative
Secondary Outcome Post-operative pain assessed using VAS score VAS score will be assessed immediately after the procedures, 1h, 3h, 6h, 12h, and 24h postoperatively
Secondary Outcome Amount of postoperative analgesic requirements within 24 hour
Secondary Outcome Patient satisfaction immediately post operative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University El Geish Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Motaz Amr Abu Sabaa El Geish Tanta 31527 Egypt
Mostafa Elawady Elgomhouria Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Elhouty mohamedsarah862@gmail.com 01093019320 Elgomhouria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Motaz Abu Sabaa motaz.abosabaa@med.tanta.edu.eg 0201000029988 El Geish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer of Anesthesia
Role Name Email Phone Street address
Public Enquiries Mostafa Elawady sasaelawady@gmail.com 01004062862 Elgomhouria
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices). Study Protocol Beginning 6 months and ending 12 months following article publication We will individual participate data and share it through the PubMed indexed journals
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