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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03704753
• Other study ID #: R18011M
• Status: Recruiting
• Phase: Phase 4
• Start date: January 25, 2019
• Est. completion date: May 31, 2025

Study information

• Verified date: October 2022
• Source: Tampere University Hospital
• Contact: Antti J Kalli, MD
• Phone: 0500723498
• Email: antti.kalli[@]sydansairaala.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
• Sodium chloride 0.9%
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).

Locations

Country	Name	City	State
Finland	Tampere Heart Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Oxycodone	24 postoperative hours