Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty
Primary Purpose
Hip Arthropathy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
control
IPS
Supra-iliac QL
Sponsored by
About this trial
This is an interventional prevention trial for Hip Arthropathy focused on measuring Anterior iliopsoas muscle space block, suprailiac anterior quadratus lumborum block, analgesia, hip arthroplasty
Eligibility Criteria
Inclusion Criteria:
- Patient acceptance.
- Age 50-80 years old.
- BMI ≤ 30 kg/m2
- ASA I - III.
- Elective total hip arthroplasty under general anesthesia.
Exclusion Criteria:
- History of allergy to the LA agents used in this study
- Skin lesion at the needle insertion site,
- Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
- Pre-existing neurological deficit in the lower extremity
- History of chronic pain and taking analgesics
- History of cognitive dysfunction or mental illness
Sites / Locations
- Faculty of medicine, zagazig universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
control group
IPS group
Supra-iliac QL group
Arm Description
patients will be operated on under general anesthesia
patients will receive an ultrasound-guided anterior iliopsoas muscle space (IPS) block
patients will receive an ultrasound-guided supra-iliac anterior quadratus lumborum (QL) block
Outcomes
Primary Outcome Measures
changes in Visual analogue scale (VAS)score
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Secondary Outcome Measures
Total dose of rescue analgesia
once the VAS score will be ≥ 3, rescue analgesia in the form of 1 μg/kg fentanyl will be given and the total dose consumed will be recorded
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05556759
Brief Title
Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty
Official Title
Anterior Iliopsoas Muscle Space Block Versus Supra-Iliac Anterior Quadratus Lumborum Block for Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Approximately 1.66 million hip fractures happen in a year worldwide. About 95% of these fractures happen in individuals older than 60 years. Surgical treatment involving THA is considered the best option for patients with hip fractures and those with degenerative changes in the hip joint, especially in the elderly, however, it is associated with moderate to severe postoperative pain.
Pain is one of the main factors limiting ambulation, increasing the risk of thromboembolism by immobility, and causing metabolic changes that affect other systems. Therefore, individualized pain management with the use of appropriate analgesia techniques is of paramount importance. Moreover, early intervention of rehabilitation aiming at a better postoperative recovery may reduce the length of hospital stay and return to daily. Effective pain management is one of the crucial components of enhanced recovery after surgery (ERAS).
Numerous regional anesthetic techniques have been used to provide analgesia following THA, including intrathecal morphine, epidural analgesia, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia, however, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
Up to investigators' knowledge, there is no study done to compare the supra-iliac approach to the anterior QL block versus the Anterior iliopsoas muscle space block as pre-emptive analgesia in patients undergoing THA under general anesthesia
Detailed Description
The acetabulum and the head of the femur combine to produce a traditional ball and socket joint in the hip. The lumbar (L1-L4) and sacral (L4-S4) plexuses both innervate the hip joint, and its sensory innervation is from the femoral (FN), obturator, and sciatic nerves with contribution from the superior gluteal nerve and nerve to quadratus femoris. Cutaneous innervation is by lateral femoral cutaneous (LFCN), subcostal iliohypogastric nerve, and the superior cluneal nerves which predominately arise from the dorsal rami of L1.
The lumbar plexus nerves, including the femoral, obturator, and lateral femoral cutaneous nerves, lie within the psoas major (PM) muscle. These nerves then exit the PM to lie within the iliopsoas compartment, between the iliacus and PM muscles. The sacral plexus is located also in the caudal extension of this anatomical space. The iliacus and psoas muscles are wrapped by the fascia iliaca. The fascia iliaca fuses superiorly with the anterior thoracolumbar fascia (transversalis fascia) that wrapped both the quadratus lumborum (QL) and the psoas muscles.
Total hip arthroplasty (THA) is a common orthopedic surgical procedure that has been successfully utilized to treat hip fractures since 1960 [4] as well, it is considered the treatment of choice for osteoarthritis of the hip joint. Both implants' types cemented and uncemented can provide good fixation, resulting in favorable long-term outcomes [5]. One of the keys to a patient's recovery following THA surgery is effective postoperative pain management. Nowadays, the concept of pain management with multimodal analgesia and regional anesthesia plays a crucial role in postoperative analgesia reducing opioids consumption and decreasing the time to mobilization. Numerous regional anesthetic techniques have been used, including patient-controlled epidural analgesia, intrathecal morphine, fascia iliaca block, lumber plexus block, sacral plexus block, and local infiltration analgesia. However, each of these techniques has specific limitations that prevent them from being the analgesic technique of choice for THA.
The ultrasound-guided (QL) block is a regional anesthetic technique that was initially proposed as an analgesic modality for abdominal surgery through many approaches: the lateral QL (QL1) block, the posterior QL (QL2) block, and the anterior QL (transmuscular) block The anterior QL block has been performed at the L3-L4 level also been used in hip surgery case reports.
A supra-iliac approach to the anterior QL block that is performed at a lower level than traditional anterior QL block approaches is considered a new approach discovered by Elsharkawy et al., and they found that a single injection between QL and Psoas muscle at the level of L5, successfully block the lumbar plexus and provide analgesia in patients undergoing total hip arthroplasty.
Anterior iliopsoas muscle space block is a new fascial block technique proposed by Dong et al., where the nerves of the lumbar plexus can be blocked by anterior injection in the iliopsoas space at the level of the anterior superior iliac spine and effectively provide perioperative analgesia for hip surgery.
This study will be designed to evaluate and compare the impact of these two fascial plane blocks for pre-emptive analgesia for patients undergoing total hip arthroplasty under general anesthesia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthropathy
Keywords
Anterior iliopsoas muscle space block, suprailiac anterior quadratus lumborum block, analgesia, hip arthroplasty
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be divided randomly by a computer-generated randomization table into three groups:
Group C :(Control group) patients will be operated on under general anesthesia. Group IPS: patients will receive anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Group Supra-iliac QL: patients will receive supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Masking
ParticipantOutcomes Assessor
Masking Description
double-blinded(participants and outcome assessors)
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
patients will be operated on under general anesthesia
Arm Title
IPS group
Arm Type
Active Comparator
Arm Description
patients will receive an ultrasound-guided anterior iliopsoas muscle space (IPS) block
Arm Title
Supra-iliac QL group
Arm Type
Active Comparator
Arm Description
patients will receive an ultrasound-guided supra-iliac anterior quadratus lumborum (QL) block
Intervention Type
Procedure
Intervention Name(s)
control
Intervention Description
patient will be operated under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
IPS
Other Intervention Name(s)
anterior iliopsoas muscle space block
Intervention Description
patients will receive ultrasound-guided anterior IPS block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Supra-iliac QL
Other Intervention Name(s)
supra-iliac anterior quadratus lumborum block
Intervention Description
patients will receive ultrasound-guided supra-iliac anterior QL block with 30 ml of bupivacaine 0.25% followed by general anesthesia.
Primary Outcome Measure Information:
Title
changes in Visual analogue scale (VAS)score
Description
On a scale of 0-10, the patient will learn to quantify postoperative pain where 0= No pain and 10= Maximum worst pain
Time Frame
measured at 1 hour, 3 hours,6 hours,12hours,18hours, 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total dose of rescue analgesia
Description
once the VAS score will be ≥ 3, rescue analgesia in the form of 1 μg/kg fentanyl will be given and the total dose consumed will be recorded
Time Frame
in the first 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient acceptance.
Age 50-80 years old.
BMI ≤ 30 kg/m2
ASA I - III.
Elective total hip arthroplasty under general anesthesia.
Exclusion Criteria:
History of allergy to the LA agents used in this study
Skin lesion at the needle insertion site,
Those with bleeding disorders, sepsis, liver disease, and psychiatric disorders
Pre-existing neurological deficit in the lower extremity
History of chronic pain and taking analgesics
History of cognitive dysfunction or mental illness
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen E Abd Ellatif, MD
Phone
01007948840
Ext
002
Email
shosh.again@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Naglaa F Abdelhaleem, MD
Phone
01003103036
Ext
002
Email
nogaahmedkareem.fa@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shereen E Abd Ellatif, MD
Organizational Affiliation
Faculty of medicine, zagazig university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine, zagazig university
City
Zagazig
State/Province
Alsharqia
ZIP/Postal Code
4115
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen E Abd Ellatif, MD
Phone
01007948840
Ext
002
Email
shosh.again@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
planned after the completion of the study and publication
IPD Sharing Time Frame
planned after the completion of the study and publication
IPD Sharing Access Criteria
contact with principal investigator
Citations:
PubMed Identifier
30953311
Citation
Elsharkawy H, El-Boghdadly K, Barnes TJ, Drake R, Maheshwari K, Soliman LM, Horn JL, Chin KJ. The supra-iliac anterior quadratus lumborum block: a cadaveric study and case series. Can J Anaesth. 2019 Aug;66(8):894-906. doi: 10.1007/s12630-019-01312-z. Epub 2019 Mar 11.
Results Reference
background
PubMed Identifier
33492871
Citation
Dong J, Zhang Y, Chen X, Ni W, Yan H, Liu Y, Shi H, Jiang W, Zhao D, Xu T. Ultrasound-guided anterior iliopsoas muscle space block versus posterior lumbar plexus block in hip surgery in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2021 Apr 1;38(4):366-373. doi: 10.1097/EJA.0000000000001452.
Results Reference
background
Citation
Chalacheewa, T, Termpornlert, S, Sa-Ngasoongsong P, Sangkum, Lisa. Regional Anesthesia for Hip Surgery Patients: Review Article. Journal of the Medical Association of Thailand 2022; 105: 152-9.
Results Reference
background
Citation
Dangle J, Kukreja P, Kalagara H. Review of Current Practices of Peripheral Nerve Blocks for Hip Fracture and Surgery. Curr Anesthesiol Rep 2020; 10:259-66.
Results Reference
background
PubMed Identifier
27513972
Citation
Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363.
Results Reference
background
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Anterior Iliopsoas Muscle Space Block Versus Supra-iliac Anterior Quadratus Lumborum Block in Total Hip Arthroplasty
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