Ultrasound-guided ESP Block vs. Wound Infiltration in Lumbar Surgery: A Comparative Analysis (ESP:Erector Spinae Plane)

Not Applicable

Completed

• Conditions: Lumbar Spinal Stenosis; Lumbar Spine Instability; Lumbar Spine Degeneration
• Interventions: Procedure: Wound infiltration; Procedure: Erector Spinae Plane Block(ESPB)

• Registration Number: NCT06567964
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.

Detailed Description

In this randomized controlled trial, 80 patients were divided into two groups: ESPB (n=40) and WI (n=40). Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at multiple time points within 24 hours. Additionally, opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), and patient satisfaction were evaluated.

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-21
• Last Update Submitted: 2024-08-21
• Study First Posted: 2024-08-23
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Elective lumbar spine surgery involving instrumentation
• ASA physical status I-III
• Ability to provide informed consent

Exclusion Criteria

• Known allergies to local anesthetics
• Coagulopathy or anticoagulant therapy
• Infection at the injection site
• Preexisting neurological disorders affecting sensory perception
• Pregnancy
• Inability to understand the visual analog scale (VAS) for pain assessment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Wound infiltration (Group WI)	Wound infiltration	Wound infiltration was performed by the surgeon at the end of the surgery via the following procedure: 1. Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe. 2. For infiltration, the anesthetic mixture was infiltrated into multiple layers of the surgical wound. This included the subcutaneous tissue and muscle layers, ensuring the even distribution of the anesthetic solution to cover the entire surgical area.
Erector Spinae Plane Block (Group E)	Erector Spinae Plane Block(ESPB)	ESPB was administered preoperatively under ultrasound guidance via a high-frequency linear probe (Sonosite M-Turbo, Fujifilm Sonosite Inc., USA) (Figure 1). The procedure was as follows: 1. Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost. 2. Ultrasound Setup: A high-frequency linear ultrasound probe was placed in a parasagittal orientation over the transverse process of the lumbar vertebra at the level of surgery. 3. Needle Insertion: After skin disinfection with chlorhexidine, a 22-gauge, 100-mm needle (Stimuplex A, B. Braun Melsungen AG, Germany) was inserted in-plane to the ultrasound probe. The needle was advanced until the tip contacted the transverse process. 4. Injection: Following negative aspiration to ensure no vascular puncture, 20 mL of 0.5% bupivacaine was injected incrementally, with real-time ultrasound visualization to confirm the correct spread of the anesthetic solution.

Primary Outcome Measures

Name	Time	Method
Postoperative pain intensity	1., 6., 12., 24., and 48. hours postoperatively	The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Time to first request for rescue analgesia	Noted in hours in the first 48 hours postoperatively	Noted in hours postoperatively
Total Opioid Consumption	In the first 48 hours postoperatively	Recorded as morphine equivalents
Incidence of Side Effects	Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively	Including nausea, vomiting, pruritus, and urinary retention,
Patient Satisfaction with Pain Management	At 48 hours postoperatively	Patient satisfaction was assessed via a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied)

Trial Locations

Locations (1)

Saglik Bilimleri Universitesi; 🇹🇷 Istanbul, Turkey