Trial Outcomes & Findings for Postoperative Pain Control Following Vitreoretinal Surgery (NCT NCT01995045)
NCT ID: NCT01995045
Last Updated: 2017-03-21
Results Overview
The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
58 participants
Primary outcome timeframe
Post-Operative Day 1 (Up to 24 hours)
Results posted on
2017-03-21
Participant Flow
Participants were recruited from Emory University Hospital between October 1, 2012 and June 17, 2016 who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both.
Of the 58 participants recruited for the study, data for 57 participants were analyzed. Data for one participant was not available for analysis.
Participant milestones
| Measure |
Bupivicaine & Triamcinolone
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
28
|
|
Overall Study
COMPLETED
|
29
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Postoperative Pain Control Following Vitreoretinal Surgery
Baseline characteristics by cohort
| Measure |
Bupivicaine & Triamcinolone
n=29 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
n=28 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-Operative Day 1 (Up to 24 hours)The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.
Outcome measures
| Measure |
Bupivicaine & Triamcinolone
n=29 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
n=28 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
|---|---|---|
|
Mean Pain Score
|
2.9 units on a scale
Standard Deviation 2.8
|
3.8 units on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Post Surgery (Up to 24 hours)The mean acetaminophen use post surgery in milligrams(mg).
Outcome measures
| Measure |
Bupivicaine & Triamcinolone
n=29 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
n=28 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
|---|---|---|
|
Mean Acetaminophen Intake
|
819 milligrams
Standard Deviation 998
|
962 milligrams
Standard Deviation 839
|
SECONDARY outcome
Timeframe: Post Surgery (Up to 24 hours)The mean hydrocodone use post surgery in milligrams(mg).
Outcome measures
| Measure |
Bupivicaine & Triamcinolone
n=29 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
n=28 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
|---|---|---|
|
Mean Hydrocodone Intake
|
.7 milligrams
Standard Deviation 2.9
|
2.8 milligrams
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Post Surgery (Up to 24 hours)The mean oxycodone use post surgery in milligrams(mg).
Outcome measures
| Measure |
Bupivicaine & Triamcinolone
n=29 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
|
Salt Solution, Bupivacaine, and Cefazolin
n=28 Participants
Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
|
|---|---|---|
|
Mean Oxycodone Intake
|
6.7 milligrams
Standard Deviation 6.8
|
9.0 milligrams
Standard Deviation 12.9
|
Adverse Events
Bupivicaine & Triamcinolone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Bupivicaine
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bupivicaine & Triamcinolone
n=29 participants at risk
Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide
Triamcinolone: Retrobulbar anesthesia
Bupivicaine Hydrochloride: Retrobulbar anesthesia
|
Bupivicaine
n=28 participants at risk
Retrobulbar anesthesia with Bupivicaine Hydrochloride
Bupivicaine Hydrochloride: Retrobulbar anesthesia
|
|---|---|---|
|
Eye disorders
Intraocular Pressure
|
3.4%
1/29 • Number of events 1
|
3.6%
1/28 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place