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.: PACTR201807122404473 Date of Approval: 16/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title ultrasound-guided Quadratus Lumborum Block
Official scientific title The effect of ultrasound-guided Quadratus Lumborum Block on the postoperative analgesia after hip surgeries: Randomized controlled study
Brief summary describing the background and objectives of the trial An ultrasound-guided transmuscular quadratus lumborum block (QLB)has begun being reported in recent years. The transmuscular QLB is injected as a local anesthetic between the psoas major (PM) and the quadratus lumborum (QL) and is indicated for postoperative pain management after abdominal surgery. The QL block has been described as an analgesic technique for abdominal surgery. Local anesthetic injected at the anterior edge of the QL muscle results in T5-L1 dermatome anesthesia because of spread to the paravertebral space. Furthermore, abdominal plane blocks have been used to provide anesthesia for hip hemiarthroplasty. Total hip arthroplasty is a common procedure often performed under spinal anaesthesia. Postoperative pain is moderate and pain relief can be achieved using spinal morphine, local infiltration analgesia patient-controlled analgesia or peripheral nerve blocks (PNB). The PROSPECT group recommends a multimodal pain management strategy using oral and intravenous drugs following THA. Recently, and with the easy availability of ultrasound technique, PNBs have become popular for postoperative pain management. especially femoral nerve block or 3-in-1 block, lumbar plexus block, psoas compartment block, and fascia iliaca compartment block.
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 14/07/2018
Actual trial start date
Anticipated date of last follow up 13/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Control Group Single shot spinal anesthesia The patients in this group will be anesthetized by single shot spinal anesthesia with hyperbaric bupivacaine 0.5% and fentanyl 30 Active-Treatment of Control Group
Experimental Group Quadratus Lumborum Grouup Single-shot spinal anesthesia with single shot Quadratus Lumborum block after the end of the surgery All the patients will receive single-shot spinal anesthesia with hyperbaric bupivacaine 0.5% and fentanyl as an anesthetic technique and a single shot Quadratus Lumborum block after the end of the surgery as a postoperative analgesia 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients ASA II and III Aged 60 to 80 years Admitted for hip surgeries  Patients who refused to participate in the research  Suspected or diagnosed coagulopathy  Allergy to bupivacaine  With major cardiac, renal, or hepatic disorders Aged: 65+ Year(s) 60 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 18/05/2018 Research Ethics Committee of Tanta Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Algeish st Tanta 31511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total dose consumption of the rescue analgesia in the first 24 hours after surgery 24 hours after surgery
Secondary Outcome The postoperative pain score, VAS score every 2 hours after the surgery till 12 h, then every 4 h till 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Hospitals Algeish st Tanta 31511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine Tanta University Algeish st Tanta 31511 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Sameh Abdelkhalik Ahmed Saied st Tanta 31511 Egypt
Muhamed Ali Abdullah El-Estad st Tanta 31511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sameh Ahmed samehabdelkhalik1982@gmail.com 00201002977048 Saied st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Lecturer of Anesthesia and Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Scientific Enquiries Salah Alsherif salahalsherif505@yahoo.com 00201020150330 Ibn Alfared st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Professor of Anesthesia and Intensive Care Faculty of Medicine Tanta University
Role Name Email Phone Street address
Public Enquiries Osama Algazar doctorosama@yahoo.com 00201226156119 Algeish st
City Postal code Country Position/Affiliation
Tanta 31511 Egypt Anesthesia specialist at Tanta General Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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