Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

NCT03117140 | Completed Phase 4 Results DMC

• 1 other identifier: 201304727
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.

Conditions

Anesthesia, Local

Keywords

Brachial Plexus Block; Clonidine; Dexamethasone; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• Duration of Analgesia

  Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off

  1-3 days post-operative

Secondary Outcomes (12)

• Block Set up Time

  Day one

• Sensory Duration of Block

  Day 1-3

• Patient Reporting Vomiting at Home

  1-3 days

• Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)

  Post-op Day 0 (Baseline)

• Number of Patients Reporting Nausea at Home

  1-3 days

Other Outcomes (2)

• Surgical Position

  Post-op Day 0 (Baseline)

• Surgical Length

  Post op Day 0 (Baseline)

Study Arms (4)

Plain Ropivacaine

ACTIVE COMPARATOR

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Drug: Ropivacaine 0.75%

Ropivacaine + Buprenorphine

EXPERIMENTAL

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine

Ropivacaine + Clonidine

EXPERIMENTAL

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Drug: Ropivacaine 0.75% + 75 mcg clonidine

Ropivaciane + Dexamethasone

EXPERIMENTAL

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Drug: Ropivacaine 0.75% + 8 mg dexamethasone

Interventions

Ropivacaine 0.75% DRUG

Only ropivacaine 0.75% is administered for this arm of the interscalene block

Also known as: Naropin

Plain Ropivacaine

Ropivacaine 0.75% + 300 mcg Buprenorphine DRUG

Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block

Also known as: Naropin + Buprenex

Ropivacaine + Buprenorphine

Ropivacaine 0.75% + 75 mcg clonidine DRUG

Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block

Also known as: Naropin + Duraclon

Ropivacaine + Clonidine

Ropivacaine 0.75% + 8 mg dexamethasone DRUG

Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block

Also known as: Naropin + Decadron

Ropivaciane + Dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have or are:
• Orthopedics service patients having shoulder surgery
• ASA(American Society of Anesthesiologists) class I, II, or III.
• Patients at least 18 years old but less than 71 years old.
• Patients giving informed consent.
• Non-Emergency Surgery

You may not qualify if:

• Patients who have or are:
• An inability to cooperate during the block placement.
• Neuropathy of the planned extremity to block
• Diabetes
• Documented Kidney Disease
• Documented Liver Disease
• A lack of or inability to give informed consent.
• Currently incarcerated.
• Pregnant

Sponsors & Collaborators

• Melinda Seering: lead

Study Sites (1)

University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic

Iowa City, Iowa, 52242, United States

Location

Related Publications (33)

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MeSH Terms

Interventions

Ropivacaine; Buprenorphine; Clonidine; Dexamethasone; Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Melinda Seering
• Organization: Univesity of Iowa Hospitals and Clinics

melinda-seering@uiowa.edu

3193561616

Study Officials

• Melinda Seering, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Profession, Prinicipal Investigator

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 17, 2017
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 3, 2018
• Results First Posted: July 3, 2018

Record last verified: 2018-07

Locations

US (1)