Clinical trial NCT02151487: A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Extremity Surgery
Keywords: Supraclavicular block
Ropivacaine
Dexamethasone
Clonidine
Postoperative analgesia
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Duration of the Sensorial Supraclavicular Block
timeFrame: within 24-hr after surgery
Secondary outcomes:
measure: Postoperative Analgesia
timeFrame: within 15 minutes at postanesthesia care unit (PACU) arrival
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Health Hospital System
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Dawood Nasir, MD
role: PRINCIPAL_INVESTIGATOR
References: