- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07240961
Lumbal Erector Spinae Plane Block for Pain Management After Total Hip Arthroplasty
Ultrasound-Guided Lumbal Erector Spinae Plane Block on Postoperative Pain Management After Total Hip Arthroplasty
The Erector Spinae Plane (ESP) block or spinal erector block was first described in September 2016 by a Canadian team. It's a block that was initially used for the treatment of chronic thoracic neuropathic pain. The ESP block is one of the inter-fascicular blocks and it's an easy-to-perform technique.In the literature, it has been reported that Lumbar ESPB provides effective analgesia after a hip surgery.
The purpose of this prospective randomized study was to compare the analgesic effects of the ultrasound-guided lumbar Erector Spinae Plane block on postoperative pain management versus the multimodal analgesia after total hip arthroplasty.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients aged more than 18 years, ASA I-III scheduled for primary total hip arthroplasty with lateral approach and under general anesthesia Patients were randomly assigned, into 1 of 2 groups, namely, group ESPBL and group Placebo, using sealed envelopes
- For ESPBL group: Lumbar ESP block performed after anesthesia induction. A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process. Erector spinae muscle will be visualized on the hyperechoic transverse process. The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
- For Placebo group: patients had multimodal analgesia without lumbar ESP block Patients will be transferred to continuous care unit for 24 hours.
Post-operative analgesia will include:
- Paracetamol 1g IV every 8 hours for 1 day then oral paracetamol 1g every 8 hours for 4 weeks.
- Diclofenac sodium(50mg) 1 tablet x 2 per day for 5 days.
- PCA morphine (Patient Controlled Analgesia), as a rescue analgesia, programmed as: Bolus of 1mg/ refractory period of 10 min/ maximum dose set up at 10mg every 12h.
The primary outcome of the study is to compare postoperative opioids consumption in the first 24 postoperative hours.
Secondary endpoints:
Secondary outcomes are: intraoperative opioid consumption, postoperative pain scores, sitting position and adverse effects related to opioids.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KAABACHI OLFA
Study Locations
-
-
-
Manouba, Tunisia, 2010
- Recruiting
- Kassab Orthopedic Institute
-
Contact:
- KAABACHI OLFA OLFA, PROFESSOR
- Phone Number: 0021098317381
- Email: olfa.kaabach@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- primary total hip arthroplasty with lateral approach and under general anesthesia .
Exclusion Criteria:
• Contraindication or refusal to regional anesthesia
- Contraindication to non-steroidal anti-inflammatory (NSAID's)
- Allergy to opioids
- Allergy to paracetamol
- Creatinine clearance < 30ml/min
- Weight<50 kg or >100kg
- Psychiatric disorders and difficulty of communication
- Lower limb neurological deficit
- Patients undergoing bilateral or revision total hip replacement
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: hip arthroplasty with nerve block
Lumbar ESP block performed after anesthesia induction.
A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process.
Erector spinae muscle will be visualized on the hyperechoic transverse process.
The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block
|
Lumbar ESP block performed after anesthesia induction.
A low-frequency ultrasound probe will be placed longitudinally 2-3 cm lateral to the L4 transverse process.
Erector spinae muscle will be visualized on the hyperechoic transverse process.
The block needle (100 mm, 22G) will be inserted cranio-caudal direction and following confirmation of the correct position of the needle, between the erectorspinae muscle and the transverse process,30 ml of local anesthetic (0.25% bupivacaine/0.2% ropivacaine) will be administered for the block.
|
|
Placebo Comparator: hip arthroplasty with intravenous pain killers
intravenous pain killers
|
intravenous pain killers
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
morphine consumption
Time Frame: Day 1
|
total morphine dose
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain scores
Time Frame: Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.
|
numerical pain rating scale [1 to 10 worse outcome]
|
Hour 2, Hour 4, Hour 6, Hour 12, Hour 18, Hour 24 and on Day 2 and Day 7.
|
|
intraoperative opioid consumption
Time Frame: end of surgery
|
total fentanyl dose
|
end of surgery
|
|
pain on sitting position
Time Frame: Day 1
|
numerical pain rating scale [1 to 10 worse outcome]
|
Day 1
|
|
QR 9 score
Time Frame: Day 2
|
quality of recovery score [0 to 18 best outcome]
|
Day 2
|
|
ROM
Time Frame: Day 1
|
Range of mouvement [0° to 90°best outcome]
|
Day 1
|
|
pain during walk
Time Frame: Day 7
|
numerical pain rating scale [1 to 10 worse outcome]
|
Day 7
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IMKO-CE 115/2024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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