USG Guided ESP Block in Spinal Surgery

NCT04148729 | Completed Phase 4 DMC

• 1 other identifier: ESP block in Spinal Surgery
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. These subjects will Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the all patient under general anaesthesia. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine will apply intravenously and diclofenac Na 75 mg intramuscularly will apply at last 30 minutes of surgery postoperative analgesia to all patients. Postoperative pain assessment will perform with visual analog scale (VAS)

Conditions

Postoperative Pain

Keywords

erector spinae plane block; postoperative analgesia; spinal surgery

Outcome Measures

Primary Outcomes (1)

• 11-point numerical rating scale score (NRS score)

  Postoperative pain assessment will perform with 11-point numerical rating scale score and numerical scale point which described by resident will record. Higher points show that severe pain. 0 point shows no pain.10 point shows unbearable pain.

  up the postoperative 24th hours.

Secondary Outcomes (1)

• Postoperative analgesic requirement

  up the postoperative 24th hours.

Study Arms (2)

bupivacaine+lidocaine

ACTIVE COMPARATOR

15 ml bupivacaine+ 5 ml lidocaine will use for USG guided ESP block under general anaesthesia with Sevuflurane and remifentanil. This block will perform at the T10 level bilaterally after induction of anaesthesia at the prone position. The patients will receive Morphine 0.1 microgram/kg intravenously and diclofenac sodium 75 mg intramuscularly at the last 30th minute of surgery. Postoperative pain assessment will perform with VAS score. The rescue analgesic 0.4 mg/kg meperidine will be apply intravenously whenever the patient requested to the analgesic.

Drug: ESP block

saline

SHAM COMPARATOR

In this group, the same volume saline will apply to the block region. The patients will receive Morphine 0.1 microgram/kg intravenously and diclofenac sodium 75 mg intramuscularly at the last 30th minute of surgery. Postoperative pain assessment will perform with VAS score. The rescue analgesic 0.4 mg/kg meperidine will be apply intravenously whenever the patient requested to the analgesic.

Drug: Control Group

Interventions

ESP block DRUG

Ultrasound guided ESP block will perform with 15 ml bupivacaine+ 5 ml lidocaine at the T10 level bilaterally. 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly will perform for postoperative analgesia.

bupivacaine+lidocaine

Control Group DRUG

In this group Ultrasound guided ESP block will not perform. Postoperative analgesia will provide with 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly.

saline

Eligibility Criteria

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

You may qualify if:

• accepting to participate the study
• ASA I-II patients
• The patients underwent spinal surgery

You may not qualify if:

• Non Volunteers
• ASA III and over
• Renal and hepatic failure
• Emergency surgical procedures

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Çukurova University

Adana, In the USA Or Canada, Please Select..., 01380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Both participants and anaesthesia providers will not know contain of the syringe.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: November 1, 2019
• Study Start: May 20, 2019
• Primary Completion: November 20, 2020
• Study Completion: December 20, 2020
• Last Updated: June 22, 2022

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)