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.: PACTR202308767038628 Date of Approval: 21/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of analgesic efficacy ultrasound guided Erector Spinae Plane block and Fascia Iliaca block in hemiarthroplasty
Official scientific title Comparison of ultrasound guided Erector Spinae Plane block and Fascia Iliaca block for Postoperative analgesia in hemiarthroplasty
Brief summary describing the background and objectives of the trial Introduction: Peripheral nerve block is one of the analgesic modalities which reduces surgical stress response, reduces opioids requirements, and improves the quality of post-operative pain control. In this study the perioperative analgesic efficacy of erector spinae plane block (ESPB) was compared to that of fascia iliaca compartment block (FICB) in Hemiarthroplasty surgery. Methodology: A Randomized Comparative Trial included sixty eight Patients who were scheduled for hemiarthroplaty surgeries at cairo university hospital.In addtion to demographic data, vital signs, pain scores, block duration, analgesics postoperative rescue doses and block failure rate were recorded. The primary outcome of the study was the first postoperative analgesic rescue which was given when the pain score exceeded 3\10. Results: Sixty eight patients were included in the final analysis (34 in each group). The time to first postoperative analgesic requirement and block duration were longer in the FICB group than in the ESPB group. Postoperative Visual analoug scale (VAS) was generally comparable between the two groups. The incidence of block failure (3 [10%] in the FICB group versus 6 [20%] in the ESPB group) and post-operative nausea and vomiting PONV (3 [10%] in the FICB group versus 3 [10%] in the ESPB group) were comparable between the two groups. Conclusion: Fascia Iliaca Compartment Block has a better perioperative analgesic profile compared to Erector Spinae Plane Block in hemiarthopalsty Surgery
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 26/06/2022
Actual trial start date 26/06/2022
Anticipated date of last follow up 04/06/2023
Actual Last follow-up date 15/06/2023
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 68
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Fascia iliaca block 1 hour We used (Siemens ACUSON X300 Ultrasound System) For ESPB, under standard aseptic technique and with the patient position prone or sitting based on comfort, the transverse processes of L4 will be identified in the parasagittal plane using a high frequency linear probe and 100 to 150 cm 22-gauge needle was inserted in-plane in a cephalad-to-caudad direction through the erector spinae muscle in between the two transverse processes, and local anesthetic {15 ml (bupivacaine 0.25%) and 15 ml (lidocaine 2%)} was injected to hydro dissect the muscle off of the transverse process and expand the ESPB. For facia iliaca block under aseptic technique, supine position a 5 MHz-12 MHz linear probe was placed parallel to inguinal ligament at inguinal crease, and the fascia iliaca, fascia Lata, femoral artery, femoral nerve as well as iliacus muscle are found. After the probe was rotated 90 to 135 degrees counterclockwise, we made this probe parallel to vertebral axis, 22G spinal needle was inserted in plane and then pushed toward the iliacus muscle and fascia iliaca. After confirmation that the needle passed through the fascia iliaca, the local anesthetic {15ml (bupivacaine 0.25%) 15ml and (lidocaine 2%)} was injected. After doing block patients were transferred to operative room (OR) where they were monitored continuously using electrocardiography, noninvasive blood pressure, peripheral oxygen saturation, and end tidal carbon dioxide throughout the surgical procedure. All of them had spinal anesthesia with volume 4ml including 25 mic fentanyl and 25 mg marqine at level lumbar 3/4. 34 Active-Treatment of Control Group
Experimental Group Erector spinae block 1 hour We used (Siemens ACUSON X300 Ultrasound System) For ESPB, under standard aseptic technique and with the patient position prone or sitting based on comfort, the transverse processes of L4 will be identified in the parasagittal plane using a high frequency linear probe and 100 to 150 cm 22-gauge needle was inserted in-plane in a cephalad-to-caudad direction through the erector spinae muscle in between the two transverse processes, and local anesthetic {15 ml (bupivacaine 0.25%) and 15 ml (lidocaine 2%)} was injected to hydro dissect the muscle off of the transverse process and expand the ESPB. 34
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.Males and females above 18. 2. I and ASA II. 3.Scheduled for Hemiarthroplasty 1.Patient refusal 2.Prolonged procedure of hemiarthroplasty more than 3 hours 3.Obese patients (Body Mass Index (BMI) more than 30) 4.local anesthetic allergy 5.Local infection at the procedure site 6.bleeding disorders or receiving anticoagulant therapy 7.psychiatric disease and cognitive disorders Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 18/01/2022 Cairo University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Kasr alainy street Giza 12556 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time of first rescue morphine dose using VAS score above 3 Vas score above 3
Secondary Outcome 1. VAS was used to assess the pain during rest. 2. VAS was used to assess the pain during movement . 3. Heart rate and mean arterial blood pressure. 4. Total morphine conusmbtion post operative 1,2,6,12 and 24 hours post operatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr alainy Kasr alainy street Cairo 12556 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Kasr alainy Kasr alainy street Giza 12556 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kasr alainy Kasr alainy street Giza 12556 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahmoud Badry mahmoud_badry2000@yahoo.com 00201001844291 Mohamed Ali Street 33
City Postal code Country Position/Affiliation
Al Omrania 12556 Egypt Cairo university school of medicine
Role Name Email Phone Street address
Scientific Enquiries Mohamed Beleta mbeleta75@gmail.com +201001007485 El haram street
City Postal code Country Position/Affiliation
Giza Egypt Kasr alainy
Role Name Email Phone Street address
Public Enquiries Mohamed Mortada Mohammeortada32@yahoo.com +201118370641 Faisal street
City Postal code Country Position/Affiliation
Giza Egypt Kasr alainy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data management and statistical analysis were performed using the Statistical Package for Social Sciences (SPSS) version. 28. All data will be available when asked All documents ( protocol- ethical committee approval- excel sheet )available when asked The study was done at Kasr Alainy hospital All study data available to the journals I will submit to publish this study Individual participant data and any documents needed related to this study will be available when the study accepted to publish Study Protocol This prospective, double blinded randomized clinical trial, study was conducted in the Orthopedic operative theater at KASR AL AINI hospital . After approval of the hospital ethical committee and after obtaining a written informed consents, 68 patients of both sexes who meet the eligibility criteria were recruited in this study . Patients were randomized using closed envelope technique into three equal groups. For 1 year I. Sample size The sample size was calculated using ClinCalc sample size calculator considering the following: The anticipated mean duration for the first morphine dose 17.5 hour for ultrasound-guided erector spinae plane block compared to 10.816 hours for fascia iliaca compartment block14, , α = 0.05, power 0.8 , β = 0.1 , and with a 1:1 ratio of group sizes. So, each group should include 36 patients with a total sample size of 72 patients. II. Statistical analysis Data Entry was carried out using SPSS (Statistical Package for Social Science) version 26.0 (IBM, SPSS, USA). Variables were examined for normality. Categorical variables were expressed in numbers and percentage; Chi square and Fisher’s exact tests were applied as appropriate. Continuous variables were expressed using mean and standard deviation or median for normally distributed data and interquartile range for not normally distributed data ; the T test, Mann Whitney and other tests of significance were used for comparison as appropriate. P value <0.05 was considered significant.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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