NCT03704753

Brief Summary

This study is divided to two sub-studies. First sub-study evaluates if Serratus Anterior Plane block (SAPB) reduces opioid consumption after thoracoscopic surgery. Secondly continuous SAPB is compared to continuous intercostal blockade. Second sub-study evaluates if Subpectoral Interfascial Plane block (SIP) reduces opioid consumption after medial sternotomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4 postoperative-pain

Timeline
Completed

Started Jan 2019

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
unknown

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

October 10, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 25, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

February 23, 2023

Status Verified

October 1, 2022

Enrollment Period

5.9 years

First QC Date

October 10, 2018

Last Update Submit

February 21, 2023

Conditions

Postoperative Pain

Keywords

Cardiac SurgeryThoracic SurgeryNerve block

Outcome Measures

Primary Outcomes (1)

  • Opioid consumption

    Oxycodone

    24 postoperative hours

Study Arms (6)

SAPB group A

ACTIVE COMPARATOR

SAPB single injection. 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery. Infection is done under ultrasound guidance.

Drug: Ropivacaine

SAPB group B

PLACEBO COMPARATOR

SAPB single injection (placebo). 30ml of SodiumChloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. Infection is done under ultrasound guidance.

Drug: Sodium chloride 0.9%

SAPB group C

ACTIVE COMPARATOR

SAPB single injection and catheter. 30ml of Ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery and a multi-holed catheter is left in place. 20ml of Ropivacaine 2mg/ml is injected every 12h through catheter postoperatively.

Drug: Ropivacaine

SAPB group D

ACTIVE COMPARATOR

Continious intercostal catheter. 20ml of Ropivacaine 7,5mg/ml is injected through intercostal catheter, which i placed under thoracoscopic visualization. After single injection a continuous infusion of Ropivacaine 2mg/ml is started (weight dependent daily dosage).

Drug: Ropivacaine

SIP group A

ACTIVE COMPARATOR

SIP single injection 20ml of Ropivacaine 7,5mg/ml is injected under pectoralis major muscle on both sides of sternum. Injection is done under ultrasound guidance.

Drug: Ropivacaine

SIP group B

PLACEBO COMPARATOR

SIP single injection (placebo) 20ml of SodiumChloride 0.9 is injected under pectoralis major muscle on both sides of sternum. Injection is done under ultrasound guidance.

Drug: Sodium chloride 0.9%

Interventions

RopivacaineDRUG

Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients

SAPB group ASAPB group CSAPB group DSIP group A
Sodium chloride 0.9%DRUG

Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).

SAPB group BSIP group B

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective thoracoscopic lung surgery or elective open heart valve surgery

You may not qualify if:

  • DM1 with complications, lack of co-operation, refusal, chronic pain, chronic intake of opioids or use of SNRI or tricyclic antidepressants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere Heart Hospital

Tampere, 33520, Finland

RECRUITING

Related Publications (1)

  • Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.

    PMID: 40627369DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

RopivacaineSodium Chloride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Central Study Contacts

Antti J Kalli, MD

CONTACT

0500723498antti.kalli@sydansairaala.fi

Kati M Järvelä, MD, PhD

CONTACT

31164869kati.jarvela@sydansairaala.fi

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised and double blinded.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 15, 2018

Study Start

January 25, 2019

Primary Completion

December 31, 2024

Study Completion

May 31, 2025

Last Updated

February 23, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)