Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

McGill University

Status and phase: Completed; Phase 4

Conditions: Post Thoracic Surgery

Treatments: Drug: Bupivacaine-epinephrine; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03862404

2017-3277

Details and patient eligibility

About

While thoracic epidural could control incisional pain after thoracotomy, an excruciating ipsilateral shoulder pain happens post thoracotomy and could affect up to 85% of thoracotomy patients. It is often difficult to manage and relatively resistant to opioids. The investigators postulate that in the presence of a functioning thoracic epidural, intrapleural bupivacaine administered through the chest tube could be effective in reducing post thoracotomy ipsilateral shoulder pain.

Enrollment: 42 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male and Female, between 18 and 80 years, ASA 1-3, Scheduled for open thoracotomy

Exclusion criteria

• ASA >3, morbid obesity BMI>40, Previous cardiac or ipsilateral thoracic surgery, Renal or hepatic failure, anemia, allergy to local anesthetics, contraindications to receive regional anesthesia, patient refusal, reiteration due to complication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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42 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

Patients in this group receive Normal Saline injection in the inter pleural space

Treatment:

Drug: Normal saline

Experimental group

Experimental group

Description:

Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space

Treatment:

Drug: Bupivacaine-epinephrine