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.: PACTR202310532688208 Date of Approval: 05/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative Analgesia after Caesarean Section
Official scientific title Ultrasound Guided Quadratus Lumborum Block versus Erector Spinae Plane Block for Postoperative Analgesia after Caesarean Section: A Comparative Study
Brief summary describing the background and objectives of the trial Relieving pain after surgery is an important clinical goal, as it has a significant impact on patient recovery and outcomes. Post operative pain impairs ambulation and convalescence, it also increases the risk of prolonged hospital stay, readmission, surgical complications and development of chronic pain. The provision of adequate analgesia is particularly important after caesarean delivery, as pain impedes maternal-infant bonding, neonatal care and initiation of breastfeeding. Major advances in the management of postoperative pain after caesarean delivery have occurred over the past few years. The use of regional analgesia techniques has proliferated significantly and has now become an important tool to provide improved pain control to post operative patients. Both Quadratus Lamborum Block [QLB] and Erector Spinae Plane Block [ESPB] are recently descriped blocks that provide effective analgesia in abdominal surgeries. Ultrasound-guided quadratus lumborum block is a recently described fascial plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves. Erector spinae plane block is a regional anesthetic technique used for postoperative pain and chronic neuropathic pain management of the thoracoabdominal region. Erector spinae plane block provides effective abdominal analgesia when performed at a lower thoracic level. Aim of the work : The aim of this study is to compare between Quadratus Lamborum Block and Erector Spinae Plane Block for post operative analgesia after Caesarean sections. Primary outcome is comparing the time to first postoperative rescue analgesic request between two groups. Secondary outcomes are Visual Analogue Score "VAS" static "at rest" & dynamic "during ambulation", hemodynamics, patient satisfaction, time to ambulation, and complications incidence eg: post operative nausea&vomiting, local anesthetic toxicity, organ injury, hematoma.
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 Prevention
Anticipated trial start date 12/02/2023
Actual trial start date 19/02/2023
Anticipated date of last follow up 15/07/2023
Actual Last follow-up date 11/09/2023
Anticipated target sample size (number of participants) 76
Actual target sample size (number of participants) 76
Recruitment status 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 group A all patients will be in supine position, tilting 45 degrees to the opposite side. A convex transducer will be placed in the transverse plane on the flank of the patients cranial to the iliac crest. The 4th lumbar vertebral transverse process, erector spinae muscle, psoas muscle and the quadrates lumborum muscle will be identified, forming the Shamrock sign. Using the hyper echoic needle ''tuohy needle G22'',inserted on the posterior corner of the convex transducer, advanced in plane under the guidance of US. After reaching the exact site of the block, the solution will be injected after negative aspiration to exclude vascular puncture. Half of the injection will be deposited between Quadratus Lamborum muscle & Erector Spinae muscle (QL2), the other half will be injected between Psoas major muscle & Quadratus Lamborum muscle (QL3). Isobaric bupivacaine HCl 0.5% (12 ml) + normal Saline NaCl 0.9% (12 ml) + 4 mg dexamethazone (1ml) Reaching volume around 25 ml on each side. once all patients will be in supine position, tilting 45 degrees to the opposite side. A convex transducer will be placed in the transverse plane on the flank of the patients cranial to the iliac crest. The 4th lumbar vertebral transverse process, erector spinae muscle, psoas muscle and the quadrates lumborum muscle will be identified, forming the Shamrock sign. Using the hyper echoic needle ''tuohy needle G22'',inserted on the posterior corner of the convex transducer, advanced in plane under the guidance of US. After reaching the exact site of the block, the solution will be injected after negative aspiration to exclude vascular puncture. Half of the injection will be deposited between Quadratus Lamborum muscle & Erector Spinae muscle (QL2), the other half will be injected between Psoas major muscle & Quadratus Lamborum muscle (QL3). 38 Active-Treatment of Control Group
Experimental Group group B Erector Spinae Block group: all patients will be in lateral position in order to place the high frequency linear probe and see the sonography clearly. Using the hyper echoic needle, advanced in plane under the guidance of US. The volume will be injected between the erector spinae muscle and transverse processes, half volume at each side, after negative aspiration to exclude vascular puncture. Isobaric bupivacaine HCl 0.5% (12 ml) + normal Saline NaCl 0.9% (12 ml) + 4 mg dexamethazone (1ml) Reaching volume around 25 ml on each side. ONCE Erector Spinae Block group: all patients will be in lateral position in order to place the high frequency linear probe and see the sonography clearly. Using the hyper echoic needle, advanced in plane under the guidance of US. The volume will be injected between the erector spinae muscle and transverse processes, half volume at each side, after negative aspiration to exclude vascular puncture. 38
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Full-term pregnant women aged 18-40 years. 2. Singleton gestation. 3. American Society of Anesthesiologists (ASA) physical status classes II. 1. Patient refusal. 2. Multiple gestation. 3. Cardiovascular disease (e.g., preeclampsia, hypertension) and the use of antihypertensive medications. 4. Chest disease. 5. Allergy or any contraindication to any of the study drugs. 6. Any contraindications for spinal anesthesia. 7. Chronic abdominal or lower back pain. 8. Drug addiction, or opioids dependence. 9. Psychiatric disorder or Inability to communicate effectively. 10.Failure of spinal anesthesia. 11.Local skin infection at block site. 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 03/10/2022 faculty of medicine menoufia university ethics and research commitee
Ethics Committee Address
Street address City Postal code Country
25 yassin abdelghaffar street, shebin elkom menoufia egypt shebin elkom 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The time to first postoperative rescue analgesic request. any time first 48 hours
Secondary Outcome Visual Analogue Score "VAS" static "at rest" & dynamic "during ambulation", hemodynamics, patient satisfaction, time to ambulation, and complications incidence eg: post operative nausea&vomiting, local anesthetic toxicity, organ injury, hematoma. 0,2,4,6,8,10,12,15,18,21,24,36,48 hours while 0 time considered time from regaining sensory and motor power
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university hospitals 25 yassin abdelghaffar street shebin elkom menoufia egypt 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
menoufia university hospital 25 yassin abdelghaffar street shebin elkom 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor anesthesia department 25 yassin abdelghaffar street shebin elkom 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled gaballah khgaballah@gmail.com 00201016009073 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom Egypt assistant proffesor anesthesia department menoufia university
Role Name Email Phone Street address
Scientific Enquiries Amany Ammar amany19764@yahoo.com 00201062037320 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt proffesor
Role Name Email Phone Street address
Public Enquiries Anas Bakr anasbakr55555@gmail.com 00201017557992 25 yassin abdelghaffar street
City Postal code Country Position/Affiliation
shebin elkom 32511 Egypt anesthesia resident
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all collected data will be available after patient deidentification Informed Consent Form,Statistical Analysis Plan,Study Protocol from start till puplication review commitee identified for this purpose
URL Results Available Results Summary Result Posting Date First Journal Publication Date
contact the principle investigator at khgaballah@gmail.com 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