This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone.
This is a prospective randomized controlled triple-masked study looking at the duration of nerve block analgesia when using the listed adjuvants (dexamethasone, buprenorphine and clonidine) plus ropivacaine versus plain ropivacaine alone. This will be looked on on patients undergoing painful shoulder surgery in the ambulatory surgery center. Patients will be randomized to one of four groups (1. 0.75% plain ropivacaine. The reference comparator 2. A mixture of 0.75% ropivacaine with 300 mcg buprenorphine 3. A mixture of 0.75% ropivacaine with 75 mcg clonidine 4. A mixture of 0.75% ropivacaine with and 8mg dexamethasone) for their regimen in the interscalene block for their surgery. The patients will then be called within 3 days post-operatively to follow-up. Follow-up data collected will be when did the patient experience return of pain to the operative limb (duration of analgesia), when did the patient experience return of motor function of the operative limb (duration of motor block) and when did the patient experience return of sensation of the operative limb (return of sensory block). All three of these adjuvants have been studied previously and shown to have increased analgesic duration with local anesthesia, but have never had a good comparative study. The mechanism of action of the analgesia for these adjuvants pain relief has never been shown although it is likely a indirect effect as there are animal studies looking at their effect on A and C fibers that did not show those results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Only ropivacaine 0.75% is administered for this arm of the interscalene block
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
University of Iowa Hospital and Clinics, Ambulatory Surgery Clinic
Iowa City, Iowa, United States
Duration of Analgesia
Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
Time frame: 1-3 days post-operative
Block Set up Time
Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity
Time frame: Day one
Sensory Duration of Block
Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off
Time frame: Day 1-3
Patient Reporting Vomiting at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time frame: 1-3 days
Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at
Time frame: Post-op Day 0 (Baseline)
Number of Patients Reporting Nausea at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time frame: 1-3 days
Number of Patients Reporting Nausea in the PACU
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Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
PACU (Post-Anesthesia Care Unit) assessment of nausea
Time frame: Post-op day 0 (Baseline)
Motor Duration of Block
Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off
Time frame: Day 1-3
Number of Patients With Blood Pressure (BP) Changes in the PACU
Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at
Time frame: Post-op Day 0 (baseline)
Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Blood pressure changes in Second Stage Recovery Area for patients was looked at
Time frame: Post-op Day 0 (baseline)
Pain Score Reported by Patients at First Phone Call
Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.
Time frame: Day 1-3
Number of Patients Reporting Itching in the PACU
Patients itching was assessed post-op in the PACU.
Time frame: Post-op day 0 (baseline)
Number of Patients Reporting Itching at Home
Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time frame: 1-3 days