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

Tampere University Hospital

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Ropivacaine; Drug: Sodium chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03704753

R18011M

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 6 patient groups, including a placebo group

SAPB group A

Active Comparator group

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.

Treatment:

Drug: Ropivacaine

SAPB group B

Placebo Comparator group

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.

Treatment:

Drug: Sodium chloride 0.9%

SAPB group C

Active Comparator group

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.

Treatment:

Drug: Ropivacaine

SAPB group D

Active Comparator group

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).

Treatment:

Drug: Ropivacaine

SIP group A

Active Comparator group

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.

Treatment:

Drug: Ropivacaine

SIP group B

Placebo Comparator group

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.

Treatment:

Drug: Sodium chloride 0.9%