USG Guided ESP Block in Spinal Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: ESP block; Drug: Control Group

• Registration Number: NCT04148729
• Lead Sponsor: Cukurova University

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)

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 Timeline

• Study First Submitted: 2018-08-01
• Study Start: 2019-05-20
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Primary Completion: 2020-11-20
• Study Completion: 2020-12-20
• Status Verified: 2021-04
• Last Update Submitted: 2022-06-16
• Last Update Posted: 2022-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine+lidocaine	ESP block	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.
saline	Control Group	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.

Primary Outcome Measures

Name	Time	Method
11-point numerical rating scale score (NRS score)	up the postoperative 24th hours.	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative analgesic requirement	up the postoperative 24th hours.	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.

Trial Locations

Locations (1)

Çukurova University; 🇹🇷 Adana, In The USA Or Canada, Please Select..., Turkey