New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Drug: Ropivacaine; Drug: Sodium chloride 0.9%

Detailed Description

Serratus anterior plane block (SAPB) - sub-study

In this sub-study 120 patients will be randomly assigned to one of four groups:

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

SAPB group B 30ml of Sodiumchloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. Injection is done under ultrasound guidance.

SAPB group C 30ml of Ropivacaine 7,5mg/m is injected above m. serratus anterior after thoracoscopic lung surgery. Also a multi-holed catheter is left in place. Through catheter 20ml Ropivacaine 2mg/ml is injected every 12 hours after surgery.

SAPB group D A multi-holed catheter is placed in single intercostal space under thoracoscopic visualization. 20ml of Ropivacaine 7,5mg/ml is injected after application of the catheter, also a continuous infusion of ropivacaine 2mg/ml is started. Rate of the infusion is determined by patients weight.

Subpectoral Interfascial Plane block (SIP) - sub-study

In this sub-study 80 patients will be randomly assigned to one of two groups:

SIP group A 20ml of ropivacaine 7,5mg/ml is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.

SIP group B 20ml of sodiumchloride 0.9 is injected under both pectoralis major muscles before medial sternotomy. Injection is done under ultrasound guidance.

Every patients postoperative pain is treated with intravenous oxycodone PCA-pump.

The investigators will evaluate post operative pain based on the Numeric rating Scale, 24 hours oxycodone consumption. The investigators will also evaluate post operative chronic pain using three questionnaires: EQ5D, STAIT-TRAIT and Pain Detect. In SAPB sub-study the questionnaires are done three weeks and 6 months post. operatively. In SIP sub-study the questionnaires are done 6 months and 12 months post.operatively.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Antti J Kalli, MD; Phone Number: +358 0500723498; Email: antti.kalli@sydansairaala.fi
• Study Contact Backup: Name: Kati M Järvelä, MD, PhD; Phone Number: +3583 31164869; Email: kati.jarvela@sydansairaala.fi

Study Locations

• Finland
  • Tampere, Finland, 33520
    • Recruiting
    • Tampere Heart Hospital
    • Contact: Timo Porkkala, Phd; Phone Number: +358 03311664887; Email: timo.porkkala@sydansairaala.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective thoracoscopic lung surgery or elective open heart valve surgery

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SAPB group A; 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; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Placebo Comparator: SAPB group B; 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%; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
Active Comparator: SAPB group C; 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; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Active Comparator: SAPB group D; 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; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Active Comparator: SIP group A; 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; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Placebo Comparator: SIP group B; 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%; Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Oxycodone	24 postoperative hours

Collaborators and Investigators

• Sponsor: Tampere University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2019
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 15, 2018

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Thoracic Surgery; Nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: R18011M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No