| Primary | Duration of Analgesia | Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off | | Posted | | Median | Inter-Quartile Range | minutes | | 1-3 days post-operative | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
| | Units | Counts |
|---|
| Participants | - OG00040
- OG00140
- OG00240
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000911(652 to 1300)
- OG0011026.5(756.5 to 1392.5)
- OG0021181(880.5 to 1528.5)
- OG003
|
|
| |
| 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 | | Posted | | Median | Inter-Quartile Range | minutes | | Day one | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone | |
|
| 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 | | Posted | | Median | Inter-Quartile Range | minutes | | Day 1-3 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone | |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | 1-3 days | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit) | Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at | | Posted | | Count of Participants | | Participants | | Post-op Day 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone |
|
| 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. | 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 | Posted | | Count of Participants | | Participants | | 1-3 days | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Secondary | Number of Patients Reporting Nausea in the PACU | PACU (Post-Anesthesia Care Unit) assessment of nausea | | Posted | | Count of Participants | | Participants | | Post-op day 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone | |
|
| Secondary | Motor Duration of Block | Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off | | Posted | | Median | Inter-Quartile Range | minutes | | Day 1-3 | | | | ID | Title | Description |
|---|
| OG000 | Plain Ropivacaine | Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively Ropivacaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone | |
|
| 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 | 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 | Posted | | Count of Participants | | Participants | | Post-op Day 0 (baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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 | 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 | Posted | | Count of Participants | | Participants | | Post-op Day 0 (baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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. | | Posted | | Median | Inter-Quartile Range | units on a scale | | Day 1-3 | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | Ropivacaine + Dexamethasone |
|
| Secondary | Number of Patients Reporting Itching in the PACU | Patients itching was assessed post-op in the PACU. | 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 | Posted | | Count of Participants | | Participants | | Post-op day 0 (baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| 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. | | Posted | | Count of Participants | | Participants | | 1-3 days | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 |
|
| Other Pre-specified | Surgical Position | Surgical position was recorded | | Posted | | Count of Participants | | Participants | | Post-op Day 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|
| Other Pre-specified | Surgical Length | Surgical length was recorded | | Posted | | Median | Inter-Quartile Range | minutes | | Post op Day 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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 | | OG001 | 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 | | OG002 | 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 | | OG003 | 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 |
|