Efficacy of Erector Spinae Plane Block in Caridac Surgery

NCT05312957 | Completed

• 1 other identifier: AbantIBU mb6
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Opioid-based pharmacological treatment is frequently used in the treatment of pain after coronary artery bypass graft (CABG) surgery. If adequate postoperative analgesia is not provided in such surgeries, pulmonary and cardiovascular complications may develop. This study aimed to provide effective analgesia and reduce postoperative opioid consumption by applying preemptive erector spinae plane (ESP) block. Methods: A total of 50 patients who underwent CABG surgery were included in this prospective randomized controlled study. Patients were randomly divided into two groups: the ESP group and the control group. The intervention to the ESP group was applied bilaterally at the T5 level before the surgery. The primary outcome was postoperative opioid consumption; the other outcomes included visual analog scale scores, intraoperative opioid consumption, and duration of hospital stay.

Conditions

Postoperative Pain

Keywords

Erector spinae plane block,; coronary artery bypass graft surgery,; postoperative pain.; opioid consumption

Outcome Measures

Primary Outcomes (5)

• measuring opioid consumption after surgery

  tramadol consumption (mg)

  0-1hours

• measuring opioid consumption after surgery

  tramadol consumption (mg)

  1-12hours,

• measuring opioid consumption after surgery

  tramadol consumption (mg)

  12-24hours,

• measuring opioid consumption after surgery

  tramadol consumption (mg)

  24-36hours,

• measuring opioid consumption after surgery

  tramadol consumption (mg)

  36-48hours

Secondary Outcomes (9)

• Evaluation of the postoperative visual analog scale(VAS) score

  1st hours

• Evaluation of the postoperative VAS score

  2nd hours

• Evaluation of the postoperative VAS score

  4th hours

• Evaluation of the postoperative VAS score

  8th hours

• Evaluation of the postoperative VAS score

  12th hours

Study Arms (2)

Group ESP

ACTIVE COMPARATOR

The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected and When the block needle touched the transverse process,Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied

Other: erector spinae plane block

Group Control

NO INTERVENTION

Group Control: Tramadol HCL was administered from vein with a patient-controlled analgesia device after extubation.

Interventions

erector spinae plane block OTHER

Group ESP (Arm 1)The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process. The T5 transverse process is detected .When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed.Then, 20 ml of 0.25% bupivacaine was administered to this area, Group Control (Arm 2) :No intervention

Group ESP

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 50-75 years,
• at the risk of American Society of Anesthesiologists (ASA) III,
• patients who were planned off- pump CABG surgery

You may not qualify if:

• In the preoperative evaluation,
• patients with hypersensitivity to the drugs to be used or the substances in their composition
• patients moderate or severe left ventricular dysfunction, with bleeding disorders, with liver and kidney failure, with chronic obstructive pulmonary disease
• patients who do not have sufficient intellectual capacity to use the PCA device,
• patients who refused to participate in the study ----In the intraoperative period, patients who needed a cardiopulmonary bypass pump and those who needed an aortic balloon pump support -----In the postoperative period, patients for whom the extubation duration was longer than four hours and those who required re-exploration were excluded from the study

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University Medical School,

Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group ESP;The probe was placed craniocaudally in the parasagittal plane approximately 3 cm lateral to the T5 spinous process T5 transverse process is detected. When the block needle (Stimuplex B. Braun R, Melsungen, Germany) touched the transverse process, 0.5-1 mL of the 0.9% NaCl test dose was administered between the erector spinae muscle fascia and the vertebral transverse process, and the needle location was confirmed. Then, 20 ml of 0.25% bupivacaine was administered to this area, and an ESP block was applied Group Control : no intervention

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: April 6, 2022
• Study Start: October 14, 2020
• Primary Completion: April 10, 2021
• Study Completion: December 1, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)