The Effect of Erector Spinae Plane Block Performed Under Direct Vision on Postoperative Pain in Spine Surgery

NCT03960528 | Completed DMC

• 1 other identifier: S003
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Spine surgery is typically associated with severe postoperative pain. Although the number of spine surgeries has increased day by day, postoperative pain management have been limited. The recently described erector spinae plane block (ESPB) is obtained by applying the local anesthetic drug between the fascia of the erector spinae muscles and the transverse process of the vertebrae. Anatomical and radiological investigations in fresh cadavers suggest that the potential place of influence of ESPB is dorsal and ventral spinal nerve roots. A small number of publications showing the analgesic efficacy of ESP in spinal surgery have been reported in the literature. The erector spinae muscles are easily identified during spine surgery, and erector spinae plane blocks can be performed under direct vision rather than via ultrasound guidance or simply using anatomical landmarks. Therefore, the investigators aim to observe the efficacy of the under direct vision erector spinae plane block on pain scores after spinal surgery.

Conditions

Acute Pain

Keywords

spine surgery; postoperative pain; perioperative analgesia; postoperative opioid requirement

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  The total amount of morphine given by patient controlled analgesia in 24 hours will be recorded

  1 day

Secondary Outcomes (2)

• Pain intensity score

  1 day

• Postoperative nausea and vomiting

  1 day

Study Arms (2)

Under direct vision erector spinae plane block

ACTIVE COMPARATOR

20 ml bupivacaine 0,25%+ lidocaine 1% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side. Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

Procedure: Erector spinae plane block

Control group

SHAM COMPARATOR

20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side. Participants will receive morphine iv PCA in the postanesthesia care unit( 0.5mg / ml 2cc bolus 8 min lock time 2cc/h infusion)

Procedure: Control group

Interventions

Erector spinae plane block PROCEDURE

Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.

Also known as: ESP block

Under direct vision erector spinae plane block

Control group PROCEDURE

20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.

Also known as: Sham comparator

Control group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• ASA 1-2-3
• Patients scheduled for elective surgery

You may not qualify if:

• Patients with previous neurological disease symptoms (TIA, syncope, dementia, etc.)
• Allergy to drugs
• Major cardiac disease
• Renal failure
• Psychiatric disease
• Patients who refuse to participate in the study
• Chronic back and lower back pain
• Body mass index \<18.5 and \>40

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Serdar YEŞİLTAŞ, Instructor

  BEZMİALEM VAKIF UNIVERSITY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: April 18, 2019
• Primary Completion: January 10, 2020
• Study Completion: February 10, 2020
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)