Postoperative Pain in Lumbar Disc Surgery

NCT06844747 | Completed

• 1 other identifier: 2023/514/250/34
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

This study included 46 patients who underwent lumbar disc herniation surgery under general anesthesia. After the operation, US-guided ESPB was performed on Group E, and WI was performed on Group W. Postoperative pain was assessed, and the time to first analgesic requirement, total analgesic amount in 24 hours, and side effects were recorded. IBM SPSS Statistics 22 was used for statistical analyses.

Conditions

Erector Spinae Plane Block; Wound Infiltration; Lumbar Disc Herniation; Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• US-guided ESPB and WI on postoperative pain

  Postoperative pain assessment was conducted in the recovery unit using the Numeric Rating Scale (NRS) with a scale of 0 (no pain) to 10 (worst pain imaginable). Standard postoperative intravenous analgesia included 75 mg of diclofenac sodium administered every 8 hours. In cases where NRS was ≥4, rescue analgesia was provided with 100 mg of intravenous tramadol. Anesthesia duration, surgical duration, NRS scores at postoperative 1 hour, 3 hours, 12 hours, and 24 hours, time to first analgesic, and total analgesic requirement in the first 24 hours were recorded. All side effects (hypotension, bradycardia, etc.) were documented.

  postoperative 1 hour, 3 hours, 12 hours, and 24 hours

Study Arms (2)

erector spinae plane block

ACTIVE COMPARATOR

At the end of the surgery, while the patient was still intubated and in the prone position, the linear probe of a Samsung HM70 EVO ultrasound device was placed sagittally, approximately 2-3 cm lateral to the spinal cord. After identifying the erector spinae muscle and transverse processes, a 22-G, 10-mm block needle (Braun Stimuplex Ultra 360, Germany) was advanced posterior to the transverse process after reaching the bone structure. The location of the needle tip was then confirmed, 0.25% bupivacaine (20mL) was injected intermittently, and separation of the erector spinae muscle from the transverse process was observed. The procedure was applied bilaterally (22 patients)

Other: erector spinae plane block(ESPB)

wound infiltration

ACTIVE COMPARATOR

In Group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site. (24 patients)

Other: erector spinae plane block(ESPB)

Interventions

erector spinae plane block(ESPB) OTHER

ESPB group received US-guided plane block, WI group received local anaesthetic wound infiltration

Also known as: wound infiltration

erector spinae plane block; wound infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anesthesiologists (ASA) physical status I-II

You may not qualify if:

• Patients with recurrent lumbar disc herniation,
• Obesity (body mass index \>35 kg/m2),
• Infection in the surgical site,
• Known local anesthetic drug allergy,
• Chronic pain, and coagulation disorders were excluded.

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, 34865, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Intervertebral Disc Displacement; Pain, Postoperative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Irem DURMUS MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The study was initially conducted without prior registration, but a registration number is now required for publication
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study design was double-blind, prospective, randomized, and controlled, involving patients undergoing elective lumbar disc herniation surgery.The patients were randomized into two groups, the ESPB group (Group E) and the WI group (Group W), with 25 patients in each group, using a computer system. ESPB or WI was administered to the patients according to the randomization before awakening after the operation.

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 25, 2025
• Study Start: June 1, 2023
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)