- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06573931
Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty
Lumbar Erector Spinae Plane Block vs Fascia Iliaca Block vs Lumbar Plexus Block for Postoperative Analgesia for Total Hip Arthroplasty: A Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Approximately 500,000 hip arthroplasties are performed each year in the United States. Traditionally, this procedure has been performed under general anesthesia. However, neuraxial and regional anesthesia have become more commonly utilized to aid in postoperative analgesia and reduce the side effects of opioids, namely sedation, nausea, and vomiting. Postoperative pain control has a significant impact on earlier ambulation, initiation of physical therapy, better functional recovery, and overall patient satisfaction.
Lumbar erector spinae plane block (LESPB) was reported to lead to effective postoperative analgesia in hip and proximal femoral surgery.
The fascia iliaca block (FIB) is an established and effective technique, especially when US guidance and proximal approaches are used.
lumbar plexus block (LPB) could be safe because of the targeted somatic nerve block in the psoas region which prevents dispensable sympathetic block even in cardiovascular-compromised patients.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypt, 31527
- Tanta University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Undergoing total hip arthroplasty under spinal anesthesia.
Exclusion Criteria:
- Obesity (Body Mass Index > 30 kg/m2).
- Allergy to any drug used in the study.
- Contraindications to spinal anesthesia (such as Thrombocytopenia (platelets <100,000/mCL) and coagulopathy (INR >1.4 or insufficient time since stopping systemic anticoagulation)).
- Epilepsy.
- Psychiatric disease.
- Pre-existing neurologic deficits or neuropathies.
- Pregnancy.
- Pre-existing alcohol/opioid use disorder.
- Previously diagnosed with chronic pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lumbar Erector Spinae Plane Block
Patients will receive lumbar erector spinae plane block at the end of surgery.
|
Patients will receive lumbar erector spinae plane block at the end of surgery.
|
|
Experimental: Fascia Iliaca Block
Patients will receive fascia iliaca block at the end of surgery.
|
Patients will receive fascia iliaca block at the end of surgery.
|
|
Experimental: Lumbar Plexus Block
Patients will receive lumbar plexus block at the end of surgery.
|
Patients will receive lumbar plexus block at the end of surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to the 1st rescue analgesia
Time Frame: 24 hours postoperatively
|
Time to the first request for the rescue analgesia (time from end of block to first dose of morphine administrated) will be recorded.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total morphine consumption in the 1st 24h
Time Frame: 24 hours postoperatively
|
Rescue analgesia will be provided by patient-controlled analgesia (PCA) with intravenous morphine (no basal rate; bolus 1 mg, lockout 10 minutes, maximum dose 20 mg in 4 h), which will be started if the numeric rating scale (NRS)> 3. NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS).
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
NRS will be assessed at PACU, 4, 8, 16, and 24 h postoperatively.
|
24 hours postoperatively
|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as Bradycardia, hypotension, postoperative nausea and vomiting (PONV), or any other complication will be recorded.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR760/7/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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