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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06567964
Acronym
ESP
Enrollment
80
Registered
2024-08-23
Start date
2023-05-01
Completion date
2023-06-30
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis, Lumbar Spine Degeneration, Lumbar Spine Instability

Keywords

Erector Spinae Plane Block, Wound Infiltration, Postoperative Analgesia, Lumbar Spinal Surgery, Ultrasound-Guided Anesthesia, Postoperative Pain, Visual Analog Scale (VAS), Enhanced Recovery After Surgery (ERAS)

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.

Interventions

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.

PROCEDUREWound 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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Randomization and Blinding A computer-generated random number sequence was used for randomization. Allocation was concealed via sealed, opaque envelopes, which were opened just before the intervention. Both the patients and the outcome assessors were blinded to the group assignments. The anesthesiologist who administered the block was aware of the group allocation but did not participate in the postoperative assessments.

Intervention model description

Participants Eligible participants were adults aged 18-70 years who were scheduled for elective lumbar spinal surgery with instrumentation. The inclusion criteria were as follows: * Elective lumbar spine surgery involving instrumentation * ASA physical status I-III * Ability to provide informed consent The exclusion criteria were as follows: * 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 The participants were randomly allocated into one of two groups: the ESPB group (Group E) or the WI group (Group W).

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain intensity1., 6., 12., 24., and 48. hours postoperativelyThe 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

MeasureTime frameDescription
Total Opioid ConsumptionIn the first 48 hours postoperativelyRecorded as morphine equivalents
Time to first request for rescue analgesiaNoted in hours in the first 48 hours postoperativelyNoted in hours postoperatively
Incidence of Side EffectsRecorded as binary outcomes (present/absent) in the first 48 hours postoperativelyIncluding nausea, vomiting, pruritus, and urinary retention,
Patient Satisfaction with Pain ManagementAt 48 hours postoperativelyPatient satisfaction was assessed via a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026