Postoperative Pain in Lumbar Disc Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-08-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Erector Spinae Plane Block Wound Infiltration Lumbar Disc Herniation Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

The study was initially conducted without prior registration, but a registration number is now required for publication

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

erector spinae plane block(ESPB)

Intervention Type OTHER

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

wound infiltration

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

Group Type ACTIVE_COMPARATOR

erector spinae plane block(ESPB)

Intervention Type OTHER

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

Interventions

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erector spinae plane block(ESPB)

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

Intervention Type OTHER

Other Intervention Names

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wound infiltration

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes