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Completed

NCT Number: NCT06567964

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Erector Spinae Plane Block(ESPB)

Procedure

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.

Wound Infiltration

Procedure

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.

Primary outcomes

  1. Postoperative pain intensity

    Time frame: 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 outcomes

  1. Total Opioid Consumption

    Time frame: In the first 48 hours postoperatively

    Recorded as morphine equivalents

  2. Time to first request for rescue analgesia

    Time frame: Noted in hours in the first 48 hours postoperatively

    Noted in hours postoperatively

  3. Incidence of Side Effects

    Time frame: Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively

    Including nausea, vomiting, pruritus, and urinary retention,

  4. Patient Satisfaction with Pain Management

    Time frame: At 48 hours postoperatively

    Patient satisfaction was assessed via a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied)

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi

Other

Registry information

Official study title

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

Acronym: ESP

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 23, 2024
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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