Analgesia Following Lumbar Discectomy

Not Applicable

Recruiting

• Conditions: Analgesia; Disk Herniated Lumbar; Local Infiltration

• Registration Number: NCT06869889
• Lead Sponsor: Zagazig University

Brief Summary

Lumbar discectomy surgeries are often the last option for patients with disc herniation who do not improve with conservative treatments. However, these procedures can lead to significant perioperative pain that may become chronic without effective management. While intravenous opioids are commonly used for pain control, they can complicate recovery and pose risks like dependence. In contrast, regional anesthetic techniques offer advantages such as quicker recovery, better postoperative pain relief, and reduced opioid use, which can lead to shorter hospital stays. Our study aims to compare the effectiveness of the retrolaminar block with local wound infiltration for pain management following posterior lumbar discectomy surgeries, potentially improving patient outcomes.

Detailed Description

Lumbar discectomy surgeries are the last resort for disc herniation patients not responding to conservative treatment. However, these surgeries are associated with annoying perioperative pain that could be severe and progress to chronic pain if not managed properly. There is no consensus regarding the best approach for postoperative pain management following spine surgeries. Intravenous opioids are still the primary agents used for perioperative pain control, which can complicate the postoperative recovery with the associated side effects and the risk of opioid dependence. Regional anesthetic techniques for spine surgeries allow rapid recovery, prolonged postoperative analgesia, and less opioid consumption, which decreases hospital stays. The current study will compare the analgesic efficacy of the retrolaminar block to the local wound infiltration following posterior lumbar discectomy surgeries.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-10
• Study Start: 2025-03-12
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Elective surgical decompression of single-level herniated lumbar disc.

Exclusion Criteria

• Opioid-dependent patients.
• Known hypersensitivity to bupivacaine.
• Diabetic patients.
• Uncooperative patient or with altered mental status.
• Previous spine surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of patients who required rescue analgesia	The first 24 hours postoperative.	The percentage of patients who required rescue analgesia within the first 24 hours.
Total amount of opioid consumption	The first 24 hours postoperative.	The total opioid consumption within the first 24 hours postopoerative.

Secondary Outcome Measures

Name	Time	Method
The Numerical Pain Rating Scale	The first 24 hours postoperative.	On a scale of 0-10, the patient will be asked to classify postoperative pain as the following 0: no pain, and 10: maximum imaginable pain. Postoperative pain will be assessed at 1,2,4,6,12,18, and 24 hours postoperative.
Duration of the surgical intervention.	The first 2 hours.	Duration of surgery in minutes.
Patient satisfaction (quality of life questionnaire)	At the end of the first 24 hours postoperative.	Patient satisfaction will be assessed using a 7-point Likert-like verbal rating scale. The patient will be asked to express their level of satisfaction 24 hours after the procedure, using the following scale: 1 = extremely dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neutral, 5 = somewhat satisfied, 6 = satisfied, and 7 = extremely satisfied .

Trial Locations

Locations (1)

Zagazig university hospital; 🇪🇬 Zagazig, Egypt