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Completed

NCT Number: NCT02151487

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health Hospital System

Dallas, Texas, 750390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Ropivacaine alone

Other names: Noropin

Ropivacaine and Dexamethasone

Drug

Ropivacaine combination with dexamethasone

Other names: Noropin and adjuvant

ropivacaine and clonidine

Drug

Ropivacaine combination with clonidine

Other names: Noropin and adjuvants

Ropivacaine, dexamethasone and clonidine

Drug

Ropivacaine combination with dexamethasone and clonidine

Other names: Noropin and adjuvants

Primary outcomes

  1. Duration of the Sensorial Supraclavicular Block

    Time frame: 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 outcomes

  1. Postoperative Analgesia

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 30, 2014
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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