Anesthesia, Local
Conditions
Keywords
Brachial Plexus Block, Clonidine, Dexamethasone, Buprenorphine
Brief summary
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.
Detailed description
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.
Interventions
Only ropivacaine 0.75% is administered for this arm of the interscalene block
DRUGRopivacaine 0.75% + 300 mcg Buprenorphine
Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
DRUGRopivacaine 0.75% + 75 mcg clonidine
Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
DRUGRopivacaine 0.75% + 8 mg dexamethasone
Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
Sponsors
Melinda Seering
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who have or are: 1. Orthopedics service patients having shoulder surgery 2. ASA(American Society of Anesthesiologists) class I, II, or III. 3. Patients at least 18 years old but less than 71 years old. 4. Patients giving informed consent. 5. Non-Emergency Surgery
Exclusion criteria
* Patients who have or are: 1. An inability to cooperate during the block placement. 2. Neuropathy of the planned extremity to block 3. Diabetes 4. Documented Kidney Disease 5. Documented Liver Disease 6. A lack of or inability to give informed consent. 7. Currently incarcerated. 8. Pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | 1-3 days post-operative | Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Set up Time | Day one | Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity |
| Sensory Duration of Block | Day 1-3 | Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off |
| Patient Reporting Vomiting at Home | 1-3 days | 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. |
| Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | Post-op Day 0 (Baseline) | Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at |
| Number of Patients Reporting Nausea at Home | 1-3 days | 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. |
| Number of Patients Reporting Nausea in the PACU | Post-op day 0 (Baseline) | PACU (Post-Anesthesia Care Unit) assessment of nausea |
| Number of Patients Reporting Itching in the PACU | Post-op day 0 (baseline) | Patients itching was assessed post-op in the PACU. |
| Number of Patients Reporting Itching at Home | 1-3 days | 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. |
| Motor Duration of Block | Day 1-3 | Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off |
| Number of Patients With Blood Pressure (BP) Changes in the PACU | Post-op Day 0 (baseline) | Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at |
| Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | Post-op Day 0 (baseline) | Blood pressure changes in Second Stage Recovery Area for patients was looked at |
| Pain Score Reported by Patients at First Phone Call | Day 1-3 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Surgical Position | Post-op Day 0 (Baseline) | Surgical position was recorded |
| Surgical Length | Post op Day 0 (Baseline) | Surgical length was recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plain Ropivacaine Plain ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block | 40 |
| Ropivacaine + Buprenorphine A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block | 40 |
| Ropivacaine + Clonidine A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block | 40 |
| Ropivacaine + Dexamethasone A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively
Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block | 40 |
| Total | 160 |
Baseline characteristics
| Characteristic | Plain Ropivacaine | Ropivacaine + Buprenorphine | Ropivacaine + Clonidine | Ropivacaine + Dexamethasone | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 2 Participants | 1 Participants | 0 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 38 Participants | 39 Participants | 40 Participants | 154 Participants |
| Age, Continuous | 45.38 years STANDARD_DEVIATION 14.39 | 44.8 years STANDARD_DEVIATION 14.2 | 43.1 years STANDARD_DEVIATION 14.74 | 42.3 years STANDARD_DEVIATION 13.71 | 43.89 years STANDARD_DEVIATION 14.19 |
| ASA (American Society of Anesthesiolgy) Classification system ASA classification I | 13 Participants | 14 Participants | 15 Participants | 17 Participants | 59 Participants |
| ASA (American Society of Anesthesiolgy) Classification system ASA classification II | 23 Participants | 24 Participants | 18 Participants | 21 Participants | 86 Participants |
| ASA (American Society of Anesthesiolgy) Classification system ASA classification III | 4 Participants | 2 Participants | 7 Participants | 2 Participants | 15 Participants |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 9 Participants | 7 Participants | 9 Participants | 40 Participants |
| Sex: Female, Male Male | 25 Participants | 31 Participants | 33 Participants | 31 Participants | 120 Participants |
| Weight | 98.82 kilograms STANDARD_DEVIATION 22.71 | 98.13 kilograms STANDARD_DEVIATION 21.47 | 99.78 kilograms STANDARD_DEVIATION 25.95 | 95.63 kilograms STANDARD_DEVIATION 21.41 | 98.09 kilograms STANDARD_DEVIATION 22.79 |
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 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Duration of Analgesia | 911 minutes |
| Ropivacaine + Buprenorphine | Duration of Analgesia | 1026.5 minutes |
| Ropivacaine + Clonidine | Duration of Analgesia | 1181 minutes |
| Ropivacaine + Dexamethasone | Duration of Analgesia | 982 minutes |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Block Set up Time | 6 minutes |
| Ropivacaine + Buprenorphine | Block Set up Time | 3 minutes |
| Ropivacaine + Clonidine | Block Set up Time | 6 minutes |
| Ropivacaine + Dexamethasone | Block Set up Time | 4.5 minutes |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Motor Duration of Block | 1120 minutes |
| Ropivacaine + Buprenorphine | Motor Duration of Block | 1198 minutes |
| Ropivacaine + Clonidine | Motor Duration of Block | 1090 minutes |
| Ropivacaine + Dexamethasone | Motor Duration of Block | 1143.5 minutes |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients Reporting Itching at Home | 1 Participants |
| Ropivacaine + Buprenorphine | Number of Patients Reporting Itching at Home | 2 Participants |
| Ropivacaine + Clonidine | Number of Patients Reporting Itching at Home | 2 Participants |
| Ropivacaine + Dexamethasone | Number of Patients Reporting Itching at Home | 0 Participants |
Secondary
Number of Patients Reporting Itching in the PACU
Patients itching was assessed post-op in the PACU.
Time frame: Post-op day 0 (baseline)
Population: 1 patient in the Ropivacaine and Buprenorphine group did not obtain data on the itching in the PACU therefore was not included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients Reporting Itching in the PACU | 5 Participants |
| Ropivacaine + Buprenorphine | Number of Patients Reporting Itching in the PACU | 2 Participants |
| Ropivacaine + Clonidine | Number of Patients Reporting Itching in the PACU | 6 Participants |
| Ropivacaine + Dexamethasone | Number of Patients Reporting Itching in the PACU | 3 Participants |
Secondary
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
Population: 1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about nausea at home and therefore was not included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients Reporting Nausea at Home | 4 Participants |
| Ropivacaine + Buprenorphine | Number of Patients Reporting Nausea at Home | 9 Participants |
| Ropivacaine + Clonidine | Number of Patients Reporting Nausea at Home | 2 Participants |
| Ropivacaine + Dexamethasone | Number of Patients Reporting Nausea at Home | 3 Participants |
Secondary
Number of Patients Reporting Nausea in the PACU
PACU (Post-Anesthesia Care Unit) assessment of nausea
Time frame: Post-op day 0 (Baseline)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients Reporting Nausea in the PACU | 4 Participants |
| Ropivacaine + Buprenorphine | Number of Patients Reporting Nausea in the PACU | 9 Participants |
| Ropivacaine + Clonidine | Number of Patients Reporting Nausea in the PACU | 2 Participants |
| Ropivacaine + Dexamethasone | Number of Patients Reporting Nausea in the PACU | 9 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | 0 Participants |
| Ropivacaine + Buprenorphine | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | 1 Participants |
| Ropivacaine + Clonidine | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | 0 Participants |
| Ropivacaine + Dexamethasone | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | 0 Participants |
Secondary
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)
Population: 1 patient in Ropivacaine and Buprenorphine group did get data for the BP changes in the PACU for the study so therefore was not included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patients With Blood Pressure (BP) Changes in the PACU | 8 Participants |
| Ropivacaine + Buprenorphine | Number of Patients With Blood Pressure (BP) Changes in the PACU | 3 Participants |
| Ropivacaine + Clonidine | Number of Patients With Blood Pressure (BP) Changes in the PACU | 7 Participants |
| Ropivacaine + Dexamethasone | Number of Patients With Blood Pressure (BP) Changes in the PACU | 2 Participants |
Secondary
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)
Population: 1 patient in Ropivacaine and Buprenorphine group did not have blood pressure data obtained in the second stage area so therefore was not included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | 5 Participants |
| Ropivacaine + Buprenorphine | Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | 1 Participants |
| Ropivacaine + Clonidine | Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | 5 Participants |
| Ropivacaine + Dexamethasone | Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Pain Score Reported by Patients at First Phone Call | 4 units on a scale |
| Ropivacaine + Buprenorphine | Pain Score Reported by Patients at First Phone Call | 3 units on a scale |
| Ropivacaine + Clonidine | Pain Score Reported by Patients at First Phone Call | 4 units on a scale |
| Ropivacaine + Dexamethasone | Pain Score Reported by Patients at First Phone Call | 3 units on a scale |
Secondary
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
Population: 1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about vomiting at home and therefore was not included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Plain Ropivacaine | Patient Reporting Vomiting at Home | 0 Participants |
| Ropivacaine + Buprenorphine | Patient Reporting Vomiting at Home | 3 Participants |
| Ropivacaine + Clonidine | Patient Reporting Vomiting at Home | 2 Participants |
| Ropivacaine + Dexamethasone | Patient Reporting Vomiting at Home | 1 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Sensory Duration of Block | 923.5 minutes |
| Ropivacaine + Buprenorphine | Sensory Duration of Block | 982 minutes |
| Ropivacaine + Clonidine | Sensory Duration of Block | 940.5 minutes |
| Ropivacaine + Dexamethasone | Sensory Duration of Block | 1066 minutes |
Other Pre-specified
Surgical Length
Surgical length was recorded
Time frame: Post op Day 0 (Baseline)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Plain Ropivacaine | Surgical Length | 68.5 minutes |
| Ropivacaine + Buprenorphine | Surgical Length | 65 minutes |
| Ropivacaine + Clonidine | Surgical Length | 73.5 minutes |
| Ropivacaine + Dexamethasone | Surgical Length | 71 minutes |
Other Pre-specified
Surgical Position
Surgical position was recorded
Time frame: Post-op Day 0 (Baseline)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Plain Ropivacaine | Surgical Position | Beach Chair | 38 Participants |
| Plain Ropivacaine | Surgical Position | Supine | 0 Participants |
| Plain Ropivacaine | Surgical Position | Lateral | 2 Participants |
| Ropivacaine + Buprenorphine | Surgical Position | Beach Chair | 31 Participants |
| Ropivacaine + Buprenorphine | Surgical Position | Supine | 3 Participants |
| Ropivacaine + Buprenorphine | Surgical Position | Lateral | 6 Participants |
| Ropivacaine + Clonidine | Surgical Position | Lateral | 7 Participants |
| Ropivacaine + Clonidine | Surgical Position | Beach Chair | 31 Participants |
| Ropivacaine + Clonidine | Surgical Position | Supine | 2 Participants |
| Ropivacaine + Dexamethasone | Surgical Position | Beach Chair | 32 Participants |
| Ropivacaine + Dexamethasone | Surgical Position | Supine | 2 Participants |
| Ropivacaine + Dexamethasone | Surgical Position | Lateral | 6 Participants |