Analgesia Following Lumbar Discectomy

NCT06869889 | Active Not Recruiting

• 1 other identifier: Spine surgeries Analgesia
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Disk Herniated Lumbar; Local Infiltration

Outcome Measures

Primary Outcomes (2)

• Number of patients who required rescue analgesia

  The percentage of patients who required rescue analgesia within the first 24 hours.

  The first 24 hours postoperative.

• Total amount of opioid consumption

  The total opioid consumption within the first 24 hours postoperative.

  The first 24 hours postoperative.

Secondary Outcomes (3)

• The Numerical Pain Rating Scale

  The first 24 hours postoperative.

• Duration of the surgical intervention.

  The first 2 hours.

• Patient satisfaction (quality of life questionnaire)

  At the end of the first 24 hours postoperative.

Study Arms (2)

Retrolaminar block group

ACTIVE COMPARATOR

After confirming the correct position using imaging with a C-Arm device, the patient will receive a retrolaminar block on both sides at the level of the operated disc.

Procedure: Retrolaminar plane block

Local Infiltration group

ACTIVE COMPARATOR

The patient will receive local wound infiltration following the completion of the surgical steps with the patient in the prone position using a local anesthetic solution, tailored to the specific conditions surrounding the incision site.

Procedure: Local wound infiltration

Interventions

Retrolaminar plane block PROCEDURE

Retrolaminar plane infiltration with the local anesthetic mixture.

Retrolaminar block group

Local wound infiltration PROCEDURE

Local infiltration along the surgical incision.

Local Infiltration group

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig university hospital

Zagazig, Egypt

Location

Related Publications (4)

• Awadalla AM, Aljulayfi AS, Alrowaili AR, Souror H, Alowid F, Mahdi AMM, Hussain R, Alzahrani MM, Alsamarh AN, Alkhaldi EA, Alanazi RC. Management of Lumbar Disc Herniation: A Systematic Review. Cureus. 2023 Oct 29;15(10):e47908. doi: 10.7759/cureus.47908. eCollection 2023 Oct.

  PMID: 38034203 BACKGROUND

• Prabhakar NK, Chadwick AL, Nwaneshiudu C, Aggarwal A, Salmasi V, Lii TR, Hah JM. Management of Postoperative Pain in Patients Following Spine Surgery: A Narrative Review. Int J Gen Med. 2022 May 2;15:4535-4549. doi: 10.2147/IJGM.S292698. eCollection 2022.

  PMID: 35528286 BACKGROUND

• Tao T, Zhou Q. [Efficacy of erector spinae block versus retrolaminar block for postoperative analgesia following posterior lumbar surgery]. Nan Fang Yi Ke Da Xue Xue Bao. 2019 Jun 30;39(6):736-739. doi: 10.12122/j.issn.1673-4254.2019.06.17. Chinese.

  PMID: 31270055 BACKGROUND

• Liu D, Xu X, Zhu Y, Liu X, Zhao F, Liang G, Zhu Z. Safety and Efficacy of Ultrasound-Guided Retrolaminar Block of Multiple Injections in Retroperitoneal Laparoscopic Nephrectomy: A Prospective Randomized Controlled Study. J Pain Res. 2021 Feb 5;14:333-342. doi: 10.2147/JPR.S282500. eCollection 2021.

  PMID: 33574697 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasser Mohamed Nasr, MD

  Department of Anesthesia, Intensive Care & Pain Management, Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 11, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-09

Locations

EG (1)