Upper Extremity Surgery
Conditions
Keywords
Supraclavicular block, Ropivacaine, Dexamethasone, Clonidine, Postoperative analgesia
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.
Interventions
DRUGRopivacaine
Ropivacaine alone
Ropivacaine combination with dexamethasone
Ropivacaine combination with clonidine
DRUGRopivacaine, dexamethasone and clonidine
Ropivacaine combination with dexamethasone and clonidine
Sponsors
University of Texas Southwestern Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Pre-assignment details
Study takes place in routine clinical context. Subjects who received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants enrolled to the study.
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine Ropivacaine 0.5% 25 ml alone for supraclavicular block
Ropivacaine: Ropivacaine alone | 27 |
| Ropivacaine and Dexamethasone 25 ml 0.5% ropivacaine + 4 mg dexamethasone
Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone | 27 |
| Ropivacaine and Clonidine 25 ml 0.5% ropivacaine + 100 mcg clonidine
Ropivacaine and clonidine: Ropivacaine combination with clonidine | 20 |
| Ropivacaine, Dexamethasone and Clonidine 25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine
Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine | 23 |
| Total | 97 |
Baseline characteristics
| Characteristic | Ropivacaine | Ropivacaine and Dexamethasone | Ropivacaine and Clonidine | Ropivacaine, Dexamethasone and Clonidine | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49 years STANDARD_DEVIATION 16 | 43 years STANDARD_DEVIATION 14 | 48 years STANDARD_DEVIATION 11 | 50 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 8 Participants | 10 Participants | 41 Participants |
| Sex: Female, Male Male | 15 Participants | 9 Participants | 8 Participants | 10 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 27 | 0 / 20 | 0 / 23 |
| other Total, other adverse events | 0 / 27 | 1 / 27 | 0 / 20 | 0 / 23 |
| serious Total, serious adverse events | 0 / 27 | 0 / 27 | 0 / 20 | 0 / 23 |
Outcome results
Primary
Duration of the Sensorial Supraclavicular Block
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
Time frame: within 24-hr after surgery
Population: Participants received supraclavicular nerve block with ropivacaine alone and ropivacaine with adjuvants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Duration of the Sensorial Supraclavicular Block | 13.4 hour | Standard Deviation 6 |
| Ropivacaine and Dexamethasone | Duration of the Sensorial Supraclavicular Block | 14 hour | Standard Deviation 6.6 |
| Ropivacaine and Clonidine | Duration of the Sensorial Supraclavicular Block | 17.4 hour | Standard Deviation 6 |
| Ropivacaine, Dexamethasone and Clonidine | Duration of the Sensorial Supraclavicular Block | 18.8 hour | Standard Deviation 6.2 |
Secondary
Postoperative Analgesia
Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).
Time frame: within 15 minutes at postanesthesia care unit (PACU) arrival
Population: Patients received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants. Postoperative pain was evaluated by using Visual Analog Pain Scores on the scale of 10 (0=no pain and 10-worse pain).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ropivacaine | Postoperative Analgesia | 0 score on a scale of 10 |
| Ropivacaine and Dexamethasone | Postoperative Analgesia | 0 score on a scale of 10 |
| Ropivacaine and Clonidine | Postoperative Analgesia | 0 score on a scale of 10 |
| Ropivacaine, Dexamethasone and Clonidine | Postoperative Analgesia | 0 score on a scale of 10 |