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USG Guided ESP Block in Spinal Surgery

Ç

Çukurova University

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: ESP block
Drug: Control Group

Study type

Interventional

Funder types

Other

Identifiers

NCT04148729
ESP block in Spinal Surgery

Details and patient eligibility

About

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)

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

bupivacaine+lidocaine
Active Comparator group
Description:
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.
Treatment:
Drug: ESP block
saline
Sham Comparator group
Description:
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.
Treatment:
Drug: Control Group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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