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

NCT06567964 | Completed

• 1 other identifier: SaglikBilimleriU-KLKSH-Anes-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Total Opioid Consumption

  In the first 48 hours postoperatively

• Time to first request for rescue analgesia

  Noted in hours in the first 48 hours postoperatively

• Incidence of Side Effects

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

• Patient Satisfaction with Pain Management

  At 48 hours postoperatively

Study Arms (2)

Erector Spinae Plane Block (Group E)

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block(ESPB)

Wound infiltration (Group WI)

ACTIVE COMPARATOR

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.

Procedure: Wound infiltration

Interventions

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: 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.

Erector Spinae Plane Block (Group E)

Wound infiltration PROCEDURE

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.

Wound infiltration (Group WI)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Saglik Bilimleri Universitesi

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Yuce Y, Karakus SA, Simsek T, Onal C, Sezen O, Cevik B, Aydogmus E. Comparative efficacy of ultrasound-guided erector spinae plane block versus wound infiltration for postoperative analgesia in instrumented lumbar spinal surgeries. BMC Anesthesiol. 2024 Oct 15;24(1):374. doi: 10.1186/s12871-024-02754-9.

  PMID: 39407122 DERIVED

MeSH Terms

Conditions

Spinal Stenosis; Pain, Postoperative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yücel Yüce, MD,Assoc Prf

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: May 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)