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

NCT ID: NCT03316066

Last Updated: 2020-02-24

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2020-02-21

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.

Detailed Description

To evaluate if 2ml of 0.2% ropivacaine is less effective in decreasing pain scores by more than 50% when compared to 5ml of 0.2% ropivacaine. To evaluate if 2ml of 0.2% ropivacaine is causes less side effects when compared to 5ml after a stellate ganglion block.

Conditions

Complex Regional Pain Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 5

stellate ganglion block with ropivacaine 0.2% 5 mL

Group Type: EXPERIMENTAL

stellate ganglion block with ropivacaine 0.2% 5 mL

Intervention Type: 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

stellate ganglion block wit ropivacaine 0.2% 2 mL

Group Type: ACTIVE_COMPARATOR

stellate ganglion block wit ropivacaine 0.2% 2 mL

Intervention Type: 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.

Interventions

stellate ganglion block with ropivacaine 0.2% 5 mL

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.

Intervention Type: PROCEDURE

stellate ganglion block wit ropivacaine 0.2% 2 mL

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Veronique Brulotte

MD, MSc, FRCPC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Veronique Brulotte, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Other Identifiers

Maisonneuve RH

Identifier Type: -

Identifier Source: org_study_id