USG Guided ESP Block in Spinal Surgery

Postoperative Pain Clinical Trial

Official title:

Effect of USG Guided ESP Block in Spinal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148729
• Other study ID #: ESP block in Spinal Surgery
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2019
• Est. completion date: December 20, 2020

Study information

• Verified date: April 2021
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Çukurova University	Adana	In The USA Or Canada, Please Select...

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.