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

Upper Extremity Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02151487
• Other study ID #: 102013-068
• Status: Completed
• Start date: March 2014
• Est. completion date: August 20, 2016

Study information

• Verified date: April 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: August 20, 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Upper Extremity Surgery

Intervention

Drug:
• Ropivacaine
Ropivacaine alone
• Ropivacaine and dexamethasone
Ropivacaine combination with dexamethasone
• Ropivacaine and clonidine
Ropivacaine combination with clonidine
• Ropivacaine, dexamethasone and clonidine
Ropivacaine combination with dexamethasone and clonidine

Locations

Country	Name	City	State
United States	Parkland Health Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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