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

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Ropivacaine
Sodium chloride 0.9%
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Cardiac Surgery, Thoracic Surgery, Nerve block

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective thoracoskopic 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.

Sites / Locations

  • Tampere Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

SAPB group A

SAPB group B

SAPB group C

SAPB group D

SIP group A

SIP group B

Arm Description

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.

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.

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.

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).

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.

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.

Outcomes

Primary Outcome Measures

Opioid consumption
Oxycodone

Secondary Outcome Measures

Full Information

First Posted
October 10, 2018
Last Updated
February 21, 2023
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03704753
Brief Title
New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.
Official Title
New Truncal Nerve Blocks for Thoracoscopic Surgery and Open Heart Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Cardiac Surgery, Thoracic Surgery, Nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised and double blinded.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SAPB group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SAPB group B
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
SAPB group C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SAPB group D
Arm Type
Active Comparator
Arm Description
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).
Arm Title
SIP group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
SIP group B
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
Intervention Type
Drug
Intervention Name(s)
Sodium chloride 0.9%
Intervention Description
Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Oxycodone
Time Frame
24 postoperative hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antti J Kalli, MD
Phone
0500723498
Ext
+358
Email
antti.kalli@sydansairaala.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Kati M Järvelä, MD, PhD
Phone
31164869
Ext
+3583
Email
kati.jarvela@sydansairaala.fi
Facility Information:
Facility Name
Tampere Heart Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Porkkala, Phd
Phone
03311664887
Ext
+358
Email
timo.porkkala@sydansairaala.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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