Postoperative Pain in Lumbar Disc Surgery (Pain)

February 19, 2025 updated by: İrem DURMUS, Dr. Lutfi Kirdar Kartal Training and Research Hospital

Comparison of the Ultrasound-guided Erector Spinae Plane Block and Wound Infiltration for Postoperative Pain Management in Lumbar Disc Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34865
        • Kartal Dr Lutfi Kirdar City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Anesthesiologists (ASA) physical status I-II

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: erector spinae plane block
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)
ESPB group received US-guided plane block, WI group received local anaesthetic wound infiltration
Other Names:
  • wound infiltration
Active Comparator: wound infiltration
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)
ESPB group received US-guided plane block, WI group received local anaesthetic wound infiltration
Other Names:
  • wound infiltration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
US-guided ESPB and WI on postoperative pain
Time Frame: postoperative 1 hour, 3 hours, 12 hours, and 24 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Investigators

  • Principal Investigator: Irem DURMUS MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

August 29, 2023

Study Completion (Actual)

August 29, 2023

Study Registration Dates

First Submitted

February 12, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/514/250/34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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