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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03704753
Enrollment
200
Registered
2018-10-15
Start date
2019-01-25
Completion date
2025-05-31
Last updated
2023-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Cardiac Surgery, Thoracic Surgery, Nerve block

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.

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.

Interventions

DRUGRopivacaine

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

DRUGSodium chloride 0.9%

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

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Randomised and double blinded.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Opioid consumption24 postoperative hoursOxycodone

Countries

Finland

Contacts

Primary ContactAntti J Kalli, MD
antti.kalli@sydansairaala.fi0500723498
Backup ContactKati M Järvelä, MD, PhD
kati.jarvela@sydansairaala.fi31164869

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026