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Postoperative Pain Control Following Vitreoretinal Surgery

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ClinicalTrials.gov Identifier: NCT01995045
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : February 16, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Timothy W. Olsen, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Retinal Detachment
Proliferative Vitreoretinopathy
Retinoschisis
Interventions Drug: Triamcinolone
Drug: Bupivicaine Hydrochloride
Enrollment 58
Recruitment Details 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.
Pre-assignment Details Of the 58 participants recruited for the study, data for 57 participants were analyzed. Data for one participant was not available for analysis.
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 29 28
Completed 29 28
Not Completed 0 0
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 29 28 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  72.4%
22
  78.6%
43
  75.4%
>=65 years
8
  27.6%
6
  21.4%
14
  24.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 28 participants 57 participants
Female
8
  27.6%
8
  28.6%
16
  28.1%
Male
21
  72.4%
20
  71.4%
41
  71.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 29 participants 28 participants 57 participants
29
 100.0%
28
 100.0%
57
 100.0%
1.Primary Outcome
Title Mean Pain Score
Hide Description The mean pain score assessed by the Visual Analog Pain Scale ranging from 0-10; 10 being the worst possible pain.
Time Frame Post-Operative Day 1 (Up to 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.9  (2.8) 3.8  (2.8)
2.Secondary Outcome
Title Mean Acetaminophen Intake
Hide Description The mean acetaminophen use post surgery in milligrams(mg).
Time Frame Post Surgery (Up to 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: milligrams
819  (998) 962  (839)
3.Secondary Outcome
Title Mean Hydrocodone Intake
Hide Description The mean hydrocodone use post surgery in milligrams(mg).
Time Frame Post Surgery (Up to 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: milligrams
.7  (2.9) 2.8  (6.0)
4.Secondary Outcome
Title Mean Oxycodone Intake
Hide Description The mean oxycodone use post surgery in milligrams(mg).
Time Frame Post Surgery (Up to 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivicaine & Triamcinolone Salt Solution, Bupivacaine, and Cefazolin
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 29 28
Mean (Standard Deviation)
Unit of Measure: milligrams
6.7  (6.8) 9.0  (12.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupivicaine & Triamcinolone Bupivicaine
Hide Arm/Group Description

Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide

Triamcinolone: Retrobulbar anesthesia

Bupivicaine Hydrochloride: Retrobulbar anesthesia

Retrobulbar anesthesia with Bupivicaine Hydrochloride

Bupivicaine Hydrochloride: Retrobulbar anesthesia

All-Cause Mortality
Bupivicaine & Triamcinolone Bupivicaine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bupivicaine & Triamcinolone Bupivicaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/28 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivicaine & Triamcinolone Bupivicaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/29 (3.45%)      1/28 (3.57%)    
Eye disorders     
Intraocular Pressure   1/29 (3.45%)  1 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Timothy Olsen
Organization: Emory University
Phone: 404-778-4996
EMail: tolsen@emory.edu
Publications:
Gioia L, Prandi E, Codnotti M, Casati A,et al Peribulbar anesthesia with either 0.75% ropivacaine or a 2% lidocaine and 0.5% bupivacaine mixture for vitreoretinal surgery: a double-blinded study. Anesth Analg(89: 739-742, 1999. Shende D, Sadhasivam S, Madan R. Effects of peribulbar bupivacaine as an adjunct to general anaesthesia on peri-operative outcome following retinal detachment surgery. Anaesthesia(55): 970-975, 2000. Morel J, Pascal J, Charier D, et al. Preoperative peribulbar block in patients undergoing retinal detachment surgery under general anesthesia: a randomized double-blind study. Anesth Analg (102): 1082-1087, 2006. Ghali AM, Btarny AM. The effect on outcome of peribulbar anesthesia in conjunction with general anesthesia for vitreoretinal surgery. Anaesthesia (65): 249-253, 2010. Chavan SB, Cummings EJ.
Layout table for additonal information
Responsible Party: Timothy W. Olsen, Emory University
ClinicalTrials.gov Identifier: NCT01995045     History of Changes
Other Study ID Numbers: IRB00053514
First Submitted: November 10, 2013
First Posted: November 26, 2013
Results First Submitted: December 27, 2016
Results First Posted: February 16, 2017
Last Update Posted: March 21, 2017