NCT06584981

Brief Summary

AIM: It was aimed to evaluate the effectiveness of pectoral nerve block (PECS II), parasternal and serratus plane blocks in postoperative analgesia in minimally invasive cardiac surgery (MIDCAB). INTRODUCTION: The frequency of minimally invasive cardiac surgery has increased in recent years. With this method, Coronary artery bypass graft (CABG) operations can be performed without sternotomy. It is a beneficial method for early postoperative mobilization, early recovery and better aesthetic appearance. Since there is a surgical intervention between the ribs, pain control is important in these patients. METHOD: In the preoperative evaluation of patients planned for CABG, PECS II, parasternal and serratus plane blocks are routinely recommended for postoperative pain control. Consent for the procedure is obtained from patients who accept this procedure. After induction and before the surgical incision, these block applications are performed under sterile conditions under the guidance of ultrasonography. Standard intravenous analgesic agents are applied to our patients who do not accept block applications. The hospital core system files of our patients who underwent cardiac surgery with minimally invasive intervention in our hospital between January 1, 2021 and December 31, 2021 will be scanned retrospectively. Patients with and without block application will be divided into two groups. From our patients' files; Demographic data, extubation time, drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted. In addition, it will be noted whether there is a need for additional rescue analgesia in cases where block is performed. The data obtained will be evaluated statistically and the results will be published in national or international scientific journals.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

December 9, 2025

Status Verified

August 1, 2024

Enrollment Period

8 months

First QC Date

August 20, 2024

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Analgesic efficiency

    drain site and incision site pain at the 1st, 2nd, 4th, 12th, 24th, 48th and 72nd hours after extubation will be noted

Study Arms (2)

Patients who underwent block

ACTIVE COMPARATOR

Patients who underwent pectoral nerve block (PECS II), parasternal and serratus plane blocks will be included in this group.

Procedure: pectoral nerve block (PECS II), parasternal and serratus plane blocks

Patients who did not receive block

OTHER

Patients who were not given a block and received standard intravenous analgesics will be included in this group.

Other: analgesic

Interventions

These block applications are performed under sterile conditions under the guidance of ultrasonography

Patients who underwent block

Analgesia needs of patients who do not receive blockade are met with intravenous drugs.

Patients who did not receive block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 18 and over
  • Patients who underwent MIDCAB surgery

You may not qualify if:

  • Patients under 18 years of age
  • Patients who did not undergo MIDCAB surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hisar Intercontinental Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Gautam S, Pande S, Agarwal A, Agarwal SK, Rastogi A, Shamshery C, Singh A. Evaluation of Serratus Anterior Plane Block for Pain Relief in Patients Undergoing MIDCAB Surgery. Innovations (Phila). 2020 Mar/Apr;15(2):148-154. doi: 10.1177/1556984520908962.

  • Xin L, Wang L, Feng Y. Ultrasound-guided erector spinae plane block for postoperative analgesia in patients undergoing minimally invasive direct coronary artery bypass surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2024 Jun;71(6):784-792. doi: 10.1007/s12630-023-02637-6. Epub 2023 Nov 21.

  • Moll V, Ward CT, Jabaley CS, O'Reilly-Shah VN, Boorman DW, McKenzie-Brown AM, Halkos ME, Prabhakar A, Pyronneau LR, Schmidt PC. Erector Spinae Regional Anesthesia for Robotic Coronary Artery Bypass Surgery Is Not Associated With Reduced Postoperative Opioid Use: A Retrospective Observational Study. J Cardiothorac Vasc Anesth. 2021 Jul;35(7):2034-2042. doi: 10.1053/j.jvca.2020.09.112. Epub 2020 Sep 20.

MeSH Terms

Conditions

Pain, PostoperativeCoronary Artery Disease

Interventions

Analgesics

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Sensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesCentral Nervous System AgentsTherapeutic Uses

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hasan Huseyin Kilic

Study Record Dates

First Submitted

August 20, 2024

First Posted

September 5, 2024

Study Start

September 1, 2024

Primary Completion

April 30, 2025

Study Completion

June 30, 2025

Last Updated

December 9, 2025

Record last verified: 2024-08

Locations