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

Condition(s) targeted: Upper Extremity Fracture

Intervention: Ropivacaine (Drug); Ropivacaine, dexamethasone (Drug); Ropivacaine, dexamethasone, clonidine (Drug); Ropivacaine, clonidine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Official(s) and/or principal investigator(s):
Dawood Nasir, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center

Overall contact:
Dawood Nasir, MD, Phone: 214-590-5352, Email: Dawood.Nasir@UTSouthwestern.edu

The aim of this randomized, observer-blinded clinical trial is to evaluate the anesthetic and 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.

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 Clinical Trial to Assess the Duration of Block

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Duration of the supraclavicular block

Secondary outcome: Postoperative analgesia

Detailed description: Approximately, 50 patients in each groups undergoing orthopedic surgery of upper extremities will be 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. Patients will be identified at the day surgery unit at Parkland hospital before the procedure and will be approached by their physician, the primary investigator, or research personnel for the consent for the study. If the patient chooses and consents fully to participate, he or she will be randomly assigned to receive one of the previously described local anesthetics for supraclavicular nerve block. The following clinical outcome will be assessed for up to 24 hr: Duration of the block, onset of the block, nausea, the number of vomiting, and complications of peripheral nerve block and used medications will be recorded. Pain at rest and movement will be 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 6 hr. after the block and postoperatively immediately at PACU, 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 (via pinprick test) will be assessed. Patient will be instructed to document at what time did hand motion (finger movement) return and what time normal sensation (hot/cold) return. Specific time for both events will be asked to patient at phone call visit 24 hr later. Overall patient satisfaction will be 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 will be 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.

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women 18-80 years old

- Undergoing upper extremity surgery

- Receiving Supraclavicular 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

Dawood Nasir, MD, Phone: 214-590-5352, Email: Dawood.Nasir@UTSouthwestern.edu

Parkland Health Hospital System, Dallas, Texas 750390, United States; Recruiting
Dawood Nasir, MD, Phone: 214-590-5352, Email: Dawood.Nasir@UTSouthwestern.edu

Starting date: March 2014
Last updated: December 4, 2014