Retrolaminar Block Versus Erector Spinae Plane Block as Opioid-Free Anesthesia for Enhanced Recovery After Posterior Lumbar Discectomy

Not Applicable

Recruiting

• Conditions: Opioid-Free Anesthesia; Enhanced Recovery; Lumbar Discectomy; Retrolaminar Block; Erector Spinae Plane Block

• Registration Number: NCT06725680
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare retrolaminar block and erector spine plane block as opioid-free anesthesia for enhanced recovery after posterior lumbar discectomy.

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 Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-05
• Study First Posted: 2024-12-10
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	24 hours postoperatively	Time from end of surgery to first dose of morphine administrated.

Secondary Outcome Measures

Name	Time	Method
Time to discharge	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.
Recovery time	Till first response to verbal command (Up to 1 hour)	Time from isoflurane discontinuation to the first response to verbal command
Intraoperative fentanyl consumption	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).
Total morphine consumption	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.
Degree of pain	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").
Length of hospital stay	Till discharge from hospital (Up to 1 week)	Length of hospital stay will be recorded from the admission till discharge from hospital.
Incidence of adverse events	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt