Clinical trial NCT06567964: Ultrasound-guided ESP Block vs. Wound Infiltration in Lumbar Surgery: A Comparative Analysis (ESP:Erector Spinae Plane)
Official title: Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Lumbar Spine Instability
Lumbar Spine Degeneration
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)
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain intensity
timeFrame: 1., 6., 12., 24., and 48. hours postoperatively
Secondary outcomes:
measure: Total Opioid Consumption
timeFrame: In the first 48 hours postoperatively
measure: Time to first request for rescue analgesia
timeFrame: Noted in hours in the first 48 hours postoperatively
measure: Incidence of Side Effects
timeFrame: Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively
measure: Patient Satisfaction with Pain Management
timeFrame: At 48 hours postoperatively
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Saglik Bilimleri Universitesi
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Yücel Yüce, MD,Assoc Prf
role: PRINCIPAL_INVESTIGATOR
References: