USG Guided ESP Block in Spinal Surgery

Effect of USG Guided ESP Block in Spinal Surgery

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)

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: ESP block; Drug: Control Group

Detailed Description

American Society of Anaesthesiologist physical status I-II, aged between 18-65, 40 patients which underwent lumbar spinal surgery will recruited to this study. The patients were randomly allocated into two groups (1:1), via a computer-generated randomization list. Ultrasound (USG) guided erector spinae block will perform at T10 level (bilaterally) to the 20 patients under general anaesthesia in Group E and same volume saline will apply to the ESP block region at T10 level for control group (Group C). Total intravenous anaesthesia (propofol+remifentanil) will perform to the all patients. 15 ml bupivacaine %0.5 and 5 ml lidocaine %2 will use for USG guided ESP block. 0.1 microgram/kg morphine intravenously and diclofenac Na 75 mg intramuscularly will apply for postoperative analgesia to the all patients at last 30 minutes of surgery. Postoperative pain assessment will perform with visual analog scale (VAS). VAS, morphine consumption and complications will record. The rescue analgesic 0.4 mg/kg mepheridine will administer intravenously whenever the patient requested to the analgesic. Diclofenac sodium 75 mg will repeat to the all patients at the 12th of postoperative period, intramuscularly.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Adana, In The USA Or Canada, Please Select..., Turkey, 01380
      • Çukurova university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: bupivacaine+lidocaine; 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; 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.
Sham Comparator: saline; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesic requirement	When the higher points numerical scale point (4<) observed, additional analgesics will apply. An than, totally consumption of rescue analgesic requirement (meperidine consumotion) will calculate.	up the postoperative 24th hours.

Collaborators and Investigators

• Sponsor: Cukurova University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: August 1, 2018
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: spinal surgery; postoperative analgesia; erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: ESP block in Spinal Surgery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No