Intrapleural Bupivacaine for Ipsilateral Shoulder Pain After Thoracotomy

Double-blind Comparison of Intrapleural Bupivacaine and Saline for Ipsilateral Shoulder Pain After Thoracotomy in Patients Receiving Thoracic Epidural Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Post Thoracic Surgery
• Intervention / Treatment: Drug: Normal saline; Drug: Bupivacaine-epinephrine

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Montreal General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control group; Patients in this group receive Normal Saline injection in the inter pleural space	Drug: Normal saline; See previous descreption
Experimental: Experimental group; Patients in this group receive Bupivacaine 0.25% + Epinephrine 5 mcg/ml injection in the inter pleural space	Drug: Bupivacaine-epinephrine; See previous description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in VAS scores	ISP visual analogue scale scores before intrapleural block and at 30 min, 4 hours and 24 hours	from 0 hour to 24 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Forced Vital Capacity	from 0 hour to 48 hour
Total epidural infusion	from 0 hour to 48 hour
Co-analgesia consumption	from 0 hour to 48 hour

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 4, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 2017-3277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No