Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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