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.: PACTR202006743496362 Date of Approval: 19/06/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title US Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Post-operative Pain Management after CS
Official scientific title Ultrasound Guided Quadratus Lumborum Block versus Transversus Abdominis Plane Block in Post-operative Pain Management after Cesarean section
Brief summary describing the background and objectives of the trial Cesarean section is one of the most common surgical procedures that lead to severe postoperative pain in women. Poor pain control after C.S is associated with increased length of stay and recovery, and it also has an impact on psychological changes, quality of life, and patient satisfaction. Women having a Cesarean delivery present a unique set of challenges to the anesthetist after operation. Both Transversus Abdominis Plane Block and Quadratus lumborum block has emerged as new techniuqes for post Post-operative Pain Management after Cesarean section. The aim of this study is to compare the effect of ultrasound guided bilateral QLB versus bilateral ultrasound guided TAP block on post-operative analgesia in patients undergoing Cesarean section under spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Post operative analgesia
Anticipated trial start date 15/06/2020
Actual trial start date
Anticipated date of last follow up 15/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 Transversus Abdominis Plane Block 0.2 mL/kg of 0.25% bupivacaine per side, without exceeding the toxic dose 3 mg/kg Single Shot Injection on both sides Patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Intravenous (IV) line will be inserted and IV lactated Ringer will be started. Spinal anesthesia will be performed using spinal needle of 25-G under complete aseptic conditions (hyperbaric 0.5% bupivacaine 12 mg and fentanyl 25 µg). At the end of surgery, Transversus Abdominis Plane Block will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath. The probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In plane technique will be used, and the tip of the needle will be inserted between the internal oblique and transverse abdominis muscles. After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose 3 mg/kg. The same technique will be performed on the other side. 20 Active-Treatment of Control Group
Experimental Group Quadratus Lumborum Block 0.2 mL/kg of 0.25% bupivacaine per side, without exceeding the toxic dose 3 mg/kg Single shot injection, on both sides Patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied. Intravenous (IV) line will be inserted and IV lactated Ringer will be started. Spinal anesthesia will be performed using spinal needle of 25-G under complete aseptic conditions (hyperbaric 0.5% bupivacaine 12 mg and fentanyl 25 µg). At the end of surgery, Quadratus Lumborum Block will be performed under complete aseptic precautions using ultrasound machine with high frequency linear probe covered with sterile sheath. The probe will be placed at the level of the anterior superior iliac spine and will be moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed postero-laterally until its posterior border will be visualized, leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg, and the same technique will be performed on the other side. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Female aged from 21 to 45 years American Society of Anesthesiologists (ASA) Physical Status Class-I and II. Scheduled for elective Cesarean section. Under Spinal anesthesia. Declining to give written informed consent. History of allergy to the medications used in the study. Contraindications to regional anesthesia (including coagulopathy and local infection). Psychiatric disorder. Morbid obesity (BMI: >40kg/m2) Pregnant women going for emergency Cesarean section. Adult: 19 Year-44 Year 21 Year(s) 45 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 05/05/2020 Research Ethics Committee faculty of medicine ain shams university FAW 000017585
Ethics Committee Address
Street address City Postal code Country
Abbasia, Cairo, Egypt. Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose of pethidine used postoperatively per patient (rescue analgesia) 24 hours
Secondary Outcome Visual analogue scale immediate Postoperative, every 2 hour during the first 6 hours, and then every 6 hours there for 24 hours
Secondary Outcome Duration of postoperative analgesia time needed for first dose of pethidine to be given postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain shams University Hospitals Ramsis street, Abbasia Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Hospitals Ramsis street, Abbasia Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Ramsis street, Abbasia Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Elkholy Mahdy Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Omar Mohamed Taha Elsafty Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Hanan Mahmoud Farag Awad Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
Mohamed Saleh Ahmed Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Mohamed Saleh drsalehm2002@hotmail.com +201227761463 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Principal Investigator Ahmed Elkholy Mahdy ahmedelkholymahdy@gmail.com +201112262782 Department of Anesthesiology, Intensive Care - Faculty of Medicine - Ain Shams University
City Postal code Country Position/Affiliation
Cairo Egypt Resident of anesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data would be shared after deidentification. Study Protocol Beginning 1 months and ending 12 months following article publication. Investigators who provide a methodologically sound proposal. Proposals should be directed to corresponding author.
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