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

Completed

Conditions: Upper Extremity Surgery

Interventions: Drug: Ropivacaine
Drug: Ropivacaine and dexamethasone
Drug: Ropivacaine and clonidine
Drug: Ropivacaine, dexamethasone and clonidine

Registration Number: NCT02151487

Lead Sponsor: University of Texas Southwestern Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 97

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine	Ropivacaine 0.5% 25 ml alone for supraclavicular block
Ropivacaine and dexamethasone	Ropivacaine and dexamethasone	25 ml 0.5% ropivacaine + 4 mg dexamethasone
Ropivacaine and clonidine	Ropivacaine and clonidine	25 ml 0.5% ropivacaine + 100 mcg clonidine
Ropivacaine, dexamethasone and clonidine	Ropivacaine, dexamethasone and clonidine	25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Primary Outcome Measures

Name	Time	Method
Duration of the Sensorial Supraclavicular Block	within 24-hr after surgery	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

Secondary Outcome Measures

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