Comparison of Volumes of Local Anesthetics on the Efficiency and Safety of Stellate Ganglion Block for CRPS of the Arm

NCT03316066 | Withdrawn DMC

• 1 other identifier: Maisonneuve RH
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficiency and safety of 2ml versus 5ml of local anesthetics used in stellate ganglion blocks for the treatment of complex regional pain syndrome of the arm.

Conditions

Complex Regional Pain Syndromes

Keywords

Stellate Ganglion; Local Anesthetic

Outcome Measures

Primary Outcomes (1)

• Pain score

  Evaluate the efficiency of stellate ganglion block in decreasing pain scores 24 hours after the procedure using a verbal numeric pain rating scale.

  24 hours after the stellate ganglion block

Secondary Outcomes (9)

• Pain score

  7 days after the stellate ganglion block

• Pain score

  14 days after the stellate ganglion block

• Temperature increase in the ipsilateral arm

  1 hour after the procedure

• Horner Syndrome

  1 hour after the procedure

• Occurrence of dysphagia after a stellate ganglion block

  1 hour after the procedure

Other Outcomes (3)

• Occurrence of seizure during a stellate ganglion block

  within 30 minutes of performing the stellate ganglion block

• Occurrence of hematoma after a stellate ganglion block

  During the first 7 days after the procedure

• Occurrence of pneumothorax after a stellate ganglion block

  During the first 7 days after the procedure

Study Arms (2)

Group 5

EXPERIMENTAL

stellate ganglion block with ropivacaine 0.2% 5 mL

Procedure: stellate ganglion block with ropivacaine 0.2% 5 mL

Group 2

ACTIVE COMPARATOR

stellate ganglion block wit ropivacaine 0.2% 2 mL

Procedure: stellate ganglion block wit ropivacaine 0.2% 2 mL

Interventions

stellate ganglion block with ropivacaine 0.2% 5 mL PROCEDURE

Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.

Group 5

stellate ganglion block wit ropivacaine 0.2% 2 mL PROCEDURE

Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.

Group 2

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 with a diagnosis of complex regional pain syndrome of the arm according to the Budapest criteria and having already received a minimum of 3 stellate ganglion blocks. Only patients having received a minimum of 3 stellate ganglion blocks will be included since it is expected to have a progressive and sustained decrease in pain scores during the first 3 blocks.
• ASA 1 to 3 included

You may not qualify if:

• Patient refusal
• Contra-indications to the stellate ganglion block procedure such as coagulopathy, anticoagulants or anti platelet therapy other than aspirin, systemic or injection site infection, important neck deformity (post-radiotherapy or surgery, etc.), severe chronic obstructive pulmonary disease, contralateral diaphragm paralysis or contralateral pneumonectomy
• Allergy to local anesthetics
• Concomitant pain syndrome other than complex regional pain syndrome of the arm
• Liver or kidney failure (CrCl \< 30 ml/min)
• Inability to understand à verbal numeric pain score scale after careful explanations
• Inability to consent

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead

MeSH Terms

Conditions

Complex Regional Pain Syndromes

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Veronique Brulotte, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, FRCPC

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: October 20, 2017
• Study Start: October 20, 2018
• Primary Completion: February 21, 2020
• Study Completion: February 21, 2020
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share