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

NCT ID: NCT02151487

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2016-08-20

Brief 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.

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.

Conditions

Upper Extremity Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Ropivacaine

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine

Intervention Type: DRUG

Ropivacaine alone

Ropivacaine and dexamethasone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone

Intervention Type: DRUG

Ropivacaine combination with dexamethasone

Ropivacaine and clonidine

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine

Intervention Type: DRUG

Ropivacaine combination with clonidine

Ropivacaine, dexamethasone and clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine

Intervention Type: DRUG

Ropivacaine combination with dexamethasone and clonidine

Interventions

Ropivacaine

Ropivacaine alone

Intervention Type: DRUG

Ropivacaine and dexamethasone

Ropivacaine combination with dexamethasone

Intervention Type: DRUG

Ropivacaine and clonidine

Ropivacaine combination with clonidine

Intervention Type: DRUG

Ropivacaine, dexamethasone and clonidine

Ropivacaine combination with dexamethasone and clonidine

Intervention Type: DRUG

Other Intervention Names

Noropin; Noropin and adjuvant; Noropin and adjuvants; Noropin and adjuvants

Eligibility Criteria

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

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

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dawood Nasir

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawood Nasir, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

Parkland Health Hospital System

Dallas, Texas, United States

Countries

United States

Other Identifiers

102013-068

Identifier Type: -

Identifier Source: org_study_id