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

Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis; Lumbar Spine Degeneration; Lumbar Spine Instability
• Intervention / Treatment: Procedure: Erector Spinae Plane Block(ESPB); Procedure: Wound infiltration

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Saglik Bilimleri Universitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector Spinae Plane Block (Group E); 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: Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost.; 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.; 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.; 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.	Procedure: 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: Patient Positioning: The patient was positioned in the lateral decubitus position, with the side to be blocked uppermost.; 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.; 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.; 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.
Active Comparator: Wound infiltration (Group WI); Wound infiltration was performed by the surgeon at the end of the surgery via the following procedure: Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe.; 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.	Procedure: Wound infiltration; Wound infiltration was performed by the surgeon at the end of the surgery via the following procedure: Preparation: After hemostasis was achieved and before skin closure, 20 mL of 0.5% bupivacaine was prepared in a sterile syringe.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	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).	1., 6., 12., 24., and 48. hours postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Saglik Bilimleri Universitesi
• Investigators: Principal Investigator: Yücel Yüce, MD,Assoc Prf, Saglik Bilimleri Universitesi

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative Pain; Wound Infiltration; Postoperative Analgesia; Erector Spinae Plane Block; Enhanced Recovery After Surgery (ERAS); Visual Analog Scale (VAS); Lumbar Spinal Surgery; Ultrasound-Guided Anesthesia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: SaglikBilimleriU-KLKSH-Anes-02

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