Pain, Postoperative
Conditions
Keywords
buprenorphine, clonidine, dexamethasone, brachial plexus blocks, pain, shoulder, surgery
Brief summary
The goal of this clinical trial is to learn if there is a difference in morphine requirements in patients after upper extremity surgeries including shoulder arthroscopy. The main question it aims to answer is whether there is a difference between Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
Detailed description
This study will be a prospective randomized single-blinded clinical trial. Patients undergoing shoulder arthroscopy who meet the inclusion criteria will be invited to participate in this study. A total of 120 patients will be recruited to participate. Patients will be randomized via a 1:1 ratio to either the Interscalene block with the addition of buprenorphine, clonidine, dexamethasone group or Interscalene block alone group The null hypothesis of this research study is that there will be no significant difference in morphine requirements between the Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine and the same block without the adjuvant.
Interventions
DRUGInterscalene block with the addition of buprenorphine, clonidine, dexamethasone
Addition of the adjuvant buprenorphine, dexamethasone, and clonidine in the nerve block performed prior to shoulder arthroscopy surgery
DRUGInterscalene block with buprenorphine alone
Addition of the adjuvant buprenorphine alone the in nerve block performed prior to shoulder arthroscopy surgery
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Prospective randomized single-blinded clinical trial. 1:1 Randomization with 2 groups. Group 1: 50% of participants will receive an Interscalene brachial plexus blocks with the addition of buprenorphine, dexamethasone, and clonidine during surgery. Group 2: 50% of participants will receive an Interscalene block alone during surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients ≥ 18 years old * Patients undergoing shoulder arthroscopy * Patients willing to participate and sign informed consent
Exclusion criteria
* Severe COPD/other contraindication to general anesthesia * Patient with a weight of less than 60 kg * Dementia, not alert or oriented to person, place, or time * Chronic pain patient with daily opioid use at home. * Patient with allergy to local anesthetics * Patient refusal * Total shoulder arthroplasty * Concomitant pain in different area from operative site. * Pregnancy * Patient with active infection on the injection sites for the blocks * Patients unable or willing to understand or comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine requirement post surgery | 24 hours | To compare the morphine equivalents administered in the first 24 hours after arrival in the recovery area between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reported via a numeric rating scale (NRS) | 48 hours | To measure pain via a numeric rating scale (NRS) immediately after arrival to recovery area from surgery (time: 0hr), and again at 2, 24, and 48 hours. |
Countries
United States
Contacts
Primary ContactSusan Fargo
Outcome results
None listed