A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block

A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized Study

The aim of this randomized, observer-blinded study is to evaluate the postoperative analgesic efficacy of adding dexamethasone and clonidine to ropivacaine in supraclavicular nerve block. The investigators hypothesized that addition of dexamethasone and clonidine to ropivacaine would prolong the duration of analgesia in supraclavicular nerve block compared with ropivacaine alone.

Study Overview

• Status: Completed
• Conditions: Upper Extremity Surgery
• Intervention / Treatment: Drug: Ropivacaine; Drug: Ropivacaine and dexamethasone; Drug: Ropivacaine and clonidine; Drug: Ropivacaine, dexamethasone and clonidine

Detailed Description

Subjects undergoing orthopedic surgery of upper extremities were randomized to be one of the three groups to receive supraclavicular nerve block with group 1: ropivacaine alone; group 2: ropivacaine and dexamethasone; group 3: ropivacaine and clonidine or group 4: ropivacaine and dexamethasone and clonidine combination.

Subjects were identified at the day surgery unit at Parkland hospital before the procedure and approached by their physician, the primary investigator, or research personnel for the consent for the study. If the subjects chooses and consents fully to participate, he or she was randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block.

The following clinical outcomes were assessed for up to 24 hr: Duration of the block, onset of the block, postoperative pain scores, nausea, vomiting, and complications of peripheral nerve block. Pain was evaluated by using a linear 10-cm visual analog scale (VAS; 0=no pain, 10= worst imaginable pain) immediately before the block, 5, 10, 15 minutes and postoperatively on the arrival of Post Anesthesia Care Unit (PACU) within 15 minutes, discharge from the Day surgery Unit, and 24 hr. later at home via phone call visit.

Sensory and motor block in the related nerve dermatomes were assessed. Patient was instructed to document at what time did hand motion (finger movement) return and what time normal sensation return. Specific time for both events was sked to patient at phone call visit 24 hr later. Overall patient satisfaction was evaluated at the discharge from the day surgery and 24 hr after the block via phone visit.

At any point in which the patient is not experiencing pain relief after having received the injection, they were removed from the study and other anesthetic techniques will be applied to resolve their pain along with pharmacological management of their pain. Rescue antiemetic, which is standard of care, will be given to any patient who complains of nausea or vomiting.

• Study Type: Observational
• Enrollment (Actual): 97

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 750390
      • Parkland Health Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who scheduled to undergo upper extremity surgery requiring USSB for postoperative analgesia with ropivacaine alone or ropivacaine and adjuvants.

Description

Inclusion Criteria:

• Men and women 18-80 years old
• Undergoing upper extremity surgery
• Receiving Supraclavicular block
• Receiving ropivacaine, ropivacaine adjuvants (dexamethasone, clonidine) for the supraclavicular nerve block.
• Able to give Informed consent

Exclusion Criteria:

• Age less than 18 and greater than 80 years
• Inability to understand the study procedures
• Significant respiratory dysfunction
• Preexisting neurologic deficits
• Allergy to local anesthetics
• A bleeding diathesis or on anticoagulants
• Systemic glucocorticoid use
• Refuse to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ropivacaine; Ropivacaine 0.5% 25 ml alone for supraclavicular block	Drug: Ropivacaine; Ropivacaine alone; Other Names: Noropin
Ropivacaine and dexamethasone; 25 ml 0.5% ropivacaine + 4 mg dexamethasone	Drug: Ropivacaine and dexamethasone; Ropivacaine combination with dexamethasone; Other Names: Noropin and adjuvant
Ropivacaine and clonidine; 25 ml 0.5% ropivacaine + 100 mcg clonidine	Drug: Ropivacaine and clonidine; Ropivacaine combination with clonidine; Other Names: Noropin and adjuvants
Ropivacaine, dexamethasone and clonidine; 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine	Drug: Ropivacaine, dexamethasone and clonidine; Ropivacaine combination with dexamethasone and clonidine; Other Names: Noropin and adjuvants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the Sensorial Supraclavicular Block	Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home	within 24-hr after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Analgesia	Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).	within 15 minutes at postanesthesia care unit (PACU) arrival

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Dawood Nasir, MD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): August 20, 2016

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: May 29, 2014
• First Posted (Estimate): May 30, 2014

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: April 15, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Dexamethasone; Ropivacaine; Clonidine; Postoperative analgesia; Supraclavicular block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Sympatholytics; Dexamethasone; Dexamethasone acetate; BB 1101; Ropivacaine; Clonidine
• Other Study ID Numbers: 102013-068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No