Comparison of Postoperative Analgesic Consumption of the Erector Spina Plane Block and Serratus Anterior Plane Block

NCT03904082 | Unknown

• 1 other identifier: 2019/175
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the ability of Erector spina Plane block and Serratus Anterior Plane block to decrease postoperative pain and analgesia requirements in patients undergoing thoracotomy.

Conditions

Thoracic Diseases

Keywords

dispne, pain

Outcome Measures

Primary Outcomes (2)

• opioid consumption

  In the recovery room, all patients will given a patient- controlled analgesia device containing morphine 0.5 mg/ml, set to deliver a 1mg bolus dose of morphine with an 15 min lockout time and 6 mg 1 h limit.Total morphine consumption during the 48 hours postoperative period will recorded at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours).

  48 hours after surgery

• Verbal analog Pain Scores on rest and movement

  A Research assistant, blinded to the group allocation, interviewed patients and collected data at 6 time intervals ( 2, 4, 6, 12, 24, 48. hours) in the 48 hours postoperatively. Patients were asked to rate their pain using verbal analog scale, where 0= no pain and 10= worst pain possible.

  48 hours after surgery

Secondary Outcomes (1)

• Incidences of adverse effects (like nausea and vomitting)

  48 hours after surgery

Study Arms (3)

Erector spinae plane block group (ESP)

ACTIVE COMPARATOR

Single- shot ultrasound (Esaote Mylab30) guided ESP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) at the T4 vertebral level will performed preoperatively to patients in the ESP group (Group I).

Procedure: Erector Spinae Plane block ( Group ı)

Serratus Anterior Plane Block Group (SAP)

ACTIVE COMPARATOR

Single- shot ultrasound (Esaote Mylab30 )guided SAP block with 15 ml 0.25% bupivacain (Marcain 0.5%, Astra Zeneca, Turkey) the T4 vertebral level will performed preoperatively to patients in the SAP group( Group II).

Procedure: Serratus Anterior Plane block ( Group ıı)

Control Group

PLACEBO COMPARATOR

The Control group receive no intervetion ( Group III).

Procedure: Control Group (GROUPIII)

Interventions

Erector Spinae Plane block ( Group ı) PROCEDURE

ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Erector spinae plane block group (ESP)

Serratus Anterior Plane block ( Group ıı) PROCEDURE

SAP Block will perform preoperative to all patients in SAP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Serratus Anterior Plane Block Group (SAP)

Control Group (GROUPIII) PROCEDURE

Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I- ASA II Patients

You may not qualify if:

• history of allergy to the study medication
• refusal to participate

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Ayşe Ülgey

Kayseri, Talas, 38100, Turkey (Türkiye)

Location

Related Publications (3)

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

  PMID: 28188621 BACKGROUND

• Tulgar S, Senturk O. Ultrasound guided Erector Spinae Plane block at L-4 transverse process level provides effective postoperative analgesia for total hip arthroplasty. J Clin Anesth. 2018 Feb;44:68. doi: 10.1016/j.jclinane.2017.11.006. Epub 2017 Nov 14. No abstract available.

  PMID: 29149734 BACKGROUND

MeSH Terms

Conditions

Thoracic Diseases; Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayşe Ülgey, MD

  TC Erciyes University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: March 23, 2019
• First Posted: April 4, 2019
• Study Start: April 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: April 8, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be aailable within 10 months of study completion.
• Access Criteria: Data accep requests will be rewiewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Locations

TU (1)