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.: PACTR202408824528342 Date of Approval: 01/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The analgesic efficacy of ultrasound guided pericapsular nerve group block versus iliopsoas plane block for hip surgeries
Official scientific title The analgesic efficacy of ultrasound guided pericapsular nerve group block versus iliopsoas plane block for hip surgeries
Brief summary describing the background and objectives of the trial adequate postoperative pain management after hip surgeries is important to enhance patient well-being and to minimize the consequences of pain, Iliopsoas plane (IP) is a fascial plane deep to the iliopsoas complex that can serve as a potential space for the injection of local anesthetics to selectively block the articular branches of femoral nerve and accessory obturator nerve to the anterior hip capsule. Two highly similar ultrasound-guided interfascial plane blocks that target the IP, pericapsular nerve group (PENG) block and iliopsoas plane block (IPB), were both designed to achieve motor-sparing sensory block to the anterior hip capsule. The pericapsular nerve group (PENG) block is a novel motor-sparing technique to reduce pain after hip surgeries. This technique involves the deposition of the local anesthetic in the fascial plane between the psoas muscle and the superior pubic ramus. This is an interfascial plane block aiming to block articular branches supplied by femoral, obturator, and accessory obturator nerves. The objectives of trial is to compare the analgesic efficacy of pericapsular nerve group block , iliopsoas plane block for hip surgeries.
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 01/08/2024
Actual trial start date 01/08/2024
Anticipated date of last follow up 01/11/2024
Actual Last follow-up date 01/12/2024
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants) 66
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
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I pericapsular nerve block group PENG the local anesthetic solution (bupivacaine 0.25%) will be injected in 5-mL increments for a total volume of 20 mL while observing for adequate fluid spread in musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. the intervention will be performed 30 min before spinal anesthesia the local anesthetic solution will be injected in 5-mL increments for a total volume of 20 mL while observing for adequate fluid spread in musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. 33 Uncontrolled
Experimental Group Group II illiopsoas plane block group IPB group 20 ml of local anesthetic bupivacaine 0.25% 30 min before spinal anesthesia 20 ml of local anesthetic bupivacaine 0.25% will be injected after a needle penetration through the sartorius and iliopsoas muscle and reaching its tip into the iliopsoas plane between the iliopsoas muscle and the iliofemoral ligament 33
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
either sex aged between 21 and 80 ASA grade I ,II and grade III scheduled for elective hip surgery under subarachnoid block. • Patient refusal. • Hematological diseases, bleeding or coagulation abnormality. • Sepsis and local skin infection at site of the block. • Known hypersensitivity to the study drugs. • Associated sever uncompensated diseases :cardiac, respiratory, hepatic or renal disease. • Neuromuscular diseases (as myopathies, myasthenia gravies…) • Body mass index (BMI) more than 35 kg/m2. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 80 Year(s) Both
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 20/11/2023 institutional review board Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgomhoria street Mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total opioid consumption in the first 24 postoperative hours. postoperative 24h
Secondary Outcome Pain during positioning for giving spinal anesthesia during spinal anesthesia
Secondary Outcome Visual Analogue Scale (VAS) pain score at 2, 4, 6, 12, 18 and 24 hours postoperative
Secondary Outcome intraoperative haemodynamic changes HR,MAP 30 min after PNBs, 5 min after spinal anesthesia, then every 15 min during surgery and immediately after surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital Elgomhoria street Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura university Elgomhoria street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoria street Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dina Elwazeer elwazeerdina9@gmail.com 00201025067067 elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Dina F.Elwazeer
Role Name Email Phone Street address
Public Enquiries Reem Elsharkawy reemraouf64@gmail.com 00201006151100 elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Reem A. Elsharkawy
Role Name Email Phone Street address
Scientific Enquiries Ahmed Elshahat Dr.a.elsha7at@gmail.com 00201060343986 Elgomhoria street
City Postal code Country Position/Affiliation
Mansoura Egypt Ahmed E. mohamed
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual data that support the results will be shared beginning 9 months following publication provided the investigator who propose to use the data has approval from Institutional review board (IRB), Independent Ethics committee (IEC), or Research Ethics Board(REB) as applicable. Statistical Analysis Plan,Study Protocol within 12 months of completion of study controlled any researcher or organization covered by ethical commitee can have access to data after request of 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