- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06725680
Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy
Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Lumbar discectomy is a common procedure for patients who experience leg and back pain due to disc problems. Effective pain management is crucial for timely discharge and successful rehabilitation.
Opioid-free anesthesia is a technique that avoids the use of opioids during surgery. Enhanced recovery after surgery (ERAS) pathways are helpful strategies for incorporating opioid-free pain management techniques into clinical practice.
Erector spine plane block (ESPB) and retrolaminar block (RLB) are considered to be compartment blocks or interfacial plane blocks. In these approaches, local anesthetics are assumed to penetrate the superior costotransverse ligament and reach the paravertebral space, although the needle tip is not advanced into the paravertebral space.
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 from 18 to 65 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-II.
- Undergoing elective posterior lumbar discectomy under general anesthesia.
Exclusion Criteria:
- Body mass index (BMI) >35 kg/m2.
- Patients with disturbed mental status.
- Allergies to the drugs used in the study.
- Local infection at the puncture site.
- Cardiac insufficiency.
- Renal insufficiency.
- Coagulopathy.
- Chronic opioid use.
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: Retrolaminar block group
Patients will receive retrolaminar block after the induction of general anesthesia.
|
Patients will receive retrolaminar block after the induction of general anesthesia.
|
|
Experimental: Erector spinae plane block group
Patients will receive erector spinae plane block after the induction of general anesthesia.
|
Patients will receive erector spinae plane block after the induction of general anesthesia.
|
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 from end of surgery to first dose of morphine administrated.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative fentanyl consumption
Time Frame: Intraoperatively
|
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
|
Intraoperatively
|
|
Recovery time
Time Frame: Till first response to verbal command (Up to 1 hour)
|
Time from isoflurane discontinuation to the first response to verbal command
|
Till first response to verbal command (Up to 1 hour)
|
|
Time to discharge
Time Frame: Till the Aldrete score is ≥9 (Up to 3 hours)
|
Time from admission to the post-anesthesia care unit (PACU) to discharge from the PACU when the Aldrete score is ≥9) will be recorded.
|
Till the Aldrete score is ≥9 (Up to 3 hours)
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 0, 4, 6, 8, 12, 18, 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) score.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
|
24 hours postoperatively
|
|
Length of hospital stay
Time Frame: Till discharge from hospital (Up to 1 week)
|
Length of hospital stay will be recorded from the admission till discharge from hospital.
|
Till discharge from hospital (Up to 1 week)
|
|
Incidence of adverse events
Time Frame: 24 hours postoperatively
|
Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication related to the block such as pleural perforation, hematoma, and intraspinal diffusion 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
Other Study ID Numbers
- 36264PR936/11/24
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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