Analgesic Duration of Long Acting Local Anesthetics for Low Volume Ultrasound-guided Interscalene Brachial Plexus Block

NCT02643563 | Completed DMC

• 1 other identifier: 456-2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Severe pain following shoulder surgery is common and remains a major challenge. The interscalene nerve block is well suited for operations on the shoulder or upper arm, for providing surgical anesthesia as well as prolonged effective postoperative analgesia. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic. The current trend is to lower the volume of local anesthetic for ultrasound-guided interscalene block in order to reduce potential complications such as phrenic nerve paralysis and local anesthetic toxicity. However, at low volumes the analgesic duration of the block could be compromised. Studies to elucidate the best local anesthetic agent, concentration and adjuncts to prolong analgesia at low volumes are needed. Ropivacaine and Bupivacaine are long acting local anesthetics commonly used for peripheral nerve blocks, however, there are no studies comparing their analgesic duration in the setting of low volume interscalene block to date. This study will investigate the analgesic duration of 0.5% Ropivacaine versus 0.5% Bupivacaine with 1:200,000 epinephrine versus 1% Ropivacaine for low volume US-ISB. This study aims to conduct a comparison of the duration of post operative analgesia achieved by these agents, hence allowing the appropriate local anesthetic agent and concentration selection in low-volume techniques.

Conditions

Brachial Plexus Block; Anesthetics, Local

Keywords

Brachial Plexus Block; Anesthetics, Local

Outcome Measures

Primary Outcomes (1)

• Duration of analgesic block

  Defined as time from end of injection to first sensation of pain at surgical site

  48 hours

Secondary Outcomes (6)

• Time to first opioid consumption

  24 hours or less

• Duration of motor block

  24 hours or less

• Diaphragmatic dysfunction assessed by ultrasound

  4 hours

• Opioid consumption

  24 and 48 hours

• Pain VAS scores

  4, 8, 12, 24, 48 hours

Study Arms (3)

Ropivacaine 0.5%

EXPERIMENTAL

Low volume (5 ml) Interscalene Block with Ropivacaine 0.5%

Drug: Ropivacaine 0.5%

Ropivacaine 1%

ACTIVE COMPARATOR

Low volume (5 ml) Interscalene Block with Ropivacaine 1%

Drug: Ropivacaine 1%

Bupivacaine 0.5% + epinephrine 1:200,000

ACTIVE COMPARATOR

Low volume (5 ml) Interscalene Block with Bupivacaine 0.5% + epinephrine 1:200,000

Drug: Bupivacaine 0.5% + epinephrine 1:200,000

Interventions

Ropivacaine 0.5% DRUG

Ropivacaine 0.5% is used for low-volume ultrasound-guided interscalene brachial plexus block.

Ropivacaine 0.5%

Ropivacaine 1% DRUG

Ropivicaine 1% is used for low-volume ultrasound-guided interscalene brachial plexus block.

Ropivacaine 1%

Bupivacaine 0.5% + epinephrine 1:200,000 DRUG

Bupivacaine 0.5% + epinephrine 1:200,000 is used for low-volume ultrasound-guided interscalene brachial plexus block.

Bupivacaine 0.5% + epinephrine 1:200,000

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre
• ASA functional status class I to III
• BMI \< 35 kg/m2

You may not qualify if:

• Lack of patient consent
• Allergy to bupivacaine or ropivacaine
• BMI \> 35 kg/m2
• Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume \< 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
• Pregnant or nursing females
• Chronic opioid use defined as \> 30mg oral morphine equivalent per day

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Holland Orthopedic and Arthritic Centre

Toronto, Ontario, M2N-3Y7, Canada

Location

Related Publications (1)

• Safa B, Flynn B, McHardy PG, Kiss A, Haslam L, Henry PD, Kaustov L, Choi S. Comparison of the Analgesic Duration of 0.5% Bupivacaine With 1:200,000 Epinephrine Versus 0.5% Ropivacaine Versus 1% Ropivacaine for Low-Volume Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):1129-1137. doi: 10.1213/ANE.0000000000005373.

  PMID: 33464760 DERIVED

MeSH Terms

Interventions

Bupivacaine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Ben Safa, MD

  Sunnybrook Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: December 26, 2015
• First Posted: December 31, 2015
• Study Start: January 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: April 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

CA (1)