AxiRopiDexa: Minimal Effective Concentration (EC90) of Ropivacaine

• Sponsor: Centre Hospitalier Universitaire de Besancon (Other)
• Overall Status: Completed
• CT.gov ID: NCT03688269
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arms: 2
• Actual Duration (Months): 19
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

Prospective up and down sequential evaluation of the minimal effective concentration of perineural ropivacaine for 90% success in axillary brachial plexus block with the injection of intravenous dexamethasone or saline placebo during regional anesthesia performance

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Conduction; Ropivacaine; Dexamethasone; Axillary Brachial Plexus Block	Drug: Intravenous dexamethasone; Drug: Intravenous saline; Drug: Perineural ropivacaine	Phase 3

Detailed Description

ropivacaine concentration determined by up and down sequential method dexamethasone or saline placebo determined by randomisation

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: allocation to one of the 2 arm after randomizationallocation to one of the 2 arm after randomization
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Determination of the Minimal Effective Concentration (EC90) of Ropivacaine in Axillary Brachial Plexus Block With Intravenous Dexamethasone or Saline Injection
• Actual Study Start Date: Oct 5, 2018
• Actual Primary Completion Date: Nov 4, 2019
• Actual Study Completion Date: May 4, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intravenous dexamethasone Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 8mg/2ml Dexamethasone during the regional anesthesia	Drug: Intravenous dexamethasone; Intravenous injection of 8mg/2ml dexamethasone; Drug: Perineural ropivacaine; Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method
Placebo Comparator: Intravenous saline Axillary Brachial Plexus Block with perineural Ropivacaine. Concentration determined by sequential up and down method. Intravenous injection of 2ml Saline 0.9% during the regional anesthesia	Drug: Intravenous saline; Intravenous injection of 2ml Saline 0.9%; Drug: Perineural ropivacaine; Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method

Outcome Measures

Primary Outcome Measures

1. Surgical Effectiveness of regional anesthesia at 30min [Time of surgery]

   Ability to perform surgery under regional anaesthesia without supplementary anaesthesia

Secondary Outcome Measures

1. time between regional anesthesia and surgical incision [Time of surgery]

   time between the end of regional anesthesia and the beginning of surgical incision

2. Effectiveness of regional anaesthesia on Pin-Prick sense [Time of anaesthesia]

   Defined by a loss of pain sensation at the pinprick test at 30min after the end of regional anaesthesia

3. Effectiveness of regional anaesthesia on cold sensation [Time of anaesthesia]

   Defined by a loss of sensation of cold application on skin at 30min after the end of regional anaesthesia

4. Effectiveness of regional anaesthesia on motor function [Time of anaesthesia]

   Defined by a paresis at 30min after the end of regional anaesthesia (modified bromage score)

5. recovery of regional anesthesia: pain [first 48h]

   time to first pain sensation in the surgical wound after the end of regional anaesthesia

6. recovery of regional anesthesia: motor [first 48h]

   time to motor recovery of the arm after the end of regional anaesthesia

7. recovery of regional anesthesia: sensory [first 48h]

   time to sensory recovery of the arm after the end of regional anaesthesia

8. complication related to regional anesthesia and/or intravenous dexamethasone [month 6]

   any complication during the first 6 month after the surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years old or older

• ASA Score 1,2 et 3 (American Society of Anesthesiologists Score)

• surgery under axillary brachial plexus block

• signed information consent

Exclusion Criteria:

• pregnancy and breastfeeding

• contraindication to regional anesthesia or technical impossibility

• impaired coagulation

• delay of surgery to short to allow regional anesthesia

• dementia or under administrative supervision

• allergy and contraindication to dexamethasone or ropivacaine

• total dose of ropivacaine higher than 3 mg / kg (recommended dose for upper limb regional anesthesia)

• opioids or pain killers abuse or addiction

• steroids consumption in the past 6 months

• surgery estimated to be greater than 4 hours

• anticipated bad observation of treatment

• patient enrolled in another trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Hospitalier Universitaire de Besançon	Besançon		France	25030

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Besancon

Investigators

• Principal Investigator: Francis BERTHIER, Centre Hospitalier Universitaire de Besancon

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Besancon
• ClinicalTrials.gov Identifier: NCT03688269
• Other Study ID Numbers: P/2018/384
• First Posted: Sep 28, 2018
• Last Update Posted: Dec 21, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Besancon: regional anesthesia; dexamethasone; ropivacaine
• Additional relevant MeSH terms: Dexamethasone; Ropivacaine

Study Results

No Results Posted as of Dec 21, 2020