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Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement

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ClinicalTrials.gov Identifier: NCT00621530
Recruitment Status : Terminated (Terminated due to discontinuation of Acular PF (investigational medication))
First Posted : February 22, 2008
Results First Posted : July 27, 2017
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Institute of General Medical Sciences (NIGMS)
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hip Arthroplasty
Interventions Drug: ketorolac tromethamine opthalmic solution
Drug: placebo
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description

ketorolac 2 mg

ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery

placebo will be added to the patient's routine spinal anesthetic for surgery

placebo: placebo will be added to the patient's routine spinal anesthetic for surgery

Period Title: Overall Study
Started 30 32
Completed 28 29
Not Completed 2 3
Arm/Group Title Ketorolac Placebo Total
Hide Arm/Group Description

ketorolac 2 mg

ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery

placebo will be added to the patient's routine spinal anesthetic for surgery

placebo: placebo will be added to the patient's routine spinal anesthetic for surgery

Total of all reporting groups
Overall Number of Baseline Participants 30 32 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  90.0%
25
  78.1%
52
  83.9%
>=65 years
3
  10.0%
7
  21.9%
10
  16.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 32 participants 62 participants
Female
16
  53.3%
15
  46.9%
31
  50.0%
Male
14
  46.7%
17
  53.1%
31
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants 32 participants 62 participants
30 32 62
1.Primary Outcome
Title Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery
Hide Description Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:

ketorolac 2 mg

ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery

placebo will be added to the patient's routine spinal anesthetic for surgery

placebo: placebo will be added to the patient's routine spinal anesthetic for surgery

Overall Number of Participants Analyzed 28 29
Median (Full Range)
Unit of Measure: area in centimeters squared
0
(0 to 84)
0
(0 to 49)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments Power calculation assumed that all subjects would have an area of hypersensitivity surrounding the wound at 48 hours. We found that only 1 subject in the placebo group and 3 subjects in the ketorolac group had non-zero areas of hypersensitivity.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.94
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Final Values)
Estimated Value 0
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Present Pain Intensity
Hide Description Pain was assessed preoperatively, 2 days, and 2 and 6 months after surgery using a 0-10 (10 being worse) verbal Present Pain Intensity (PPI) scale
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were missed to follow up at different times
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
sterile saline placebo added to the patient's routine spinal anesthetic for surgery
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Preoperative Number Analyzed 28 participants 29 participants
1.7  (1.5) 1.6  (1.1)
Postoperative: 2 days Number Analyzed 28 participants 29 participants
2.1  (1.8) 2.5  (2.3)
Postoperative: 2 months Number Analyzed 28 participants 27 participants
0.6  (1.2) 0.2  (0.3)
Postoperative: 6 months Number Analyzed 23 participants 28 participants
0.4  (0.6) 0.1  (0.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.78
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
3.Secondary Outcome
Title McGill Pain Intensity
Hide Description Pain was assessed 2 days and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the intensity of their pain experience. This is termed the McGill Pain Intensity Score and is scored from 0 to 33 with 33 being the highest pain intensity.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were missed to follow up at different times
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
sterile saline placebo added to the patient's routine spinal anesthetic for surgery
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postoperative: 2 days Number Analyzed 28 participants 29 participants
11  (6.3) 10  (6.6)
Postoperative: 2 months Number Analyzed 28 participants 27 participants
2.3  (3.3) 3.1  (4.1)
Postoperative: 6 months Number Analyzed 23 participants 28 participants
1.4  (3.8) 1.2  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.87
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
4.Secondary Outcome
Title McGill Affective Pain
Hide Description Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire wherein subjects rate the degree to which adjectives describe the emotional component of their pain experience. This is termed the McGill Pain Affective Score and is scored from 0 to 12 with 12 being the highest pain emotional impact.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were missed to follow up at different times
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
ketorolac tromethamine opthalmic solution, 2 mg added to the patient's routine spinal anesthetic for surgery
sterile saline placebo added to the patient's routine spinal anesthetic for surgery
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postoperative: 2 days Number Analyzed 28 participants 29 participants
2.3  (2.5) 2.3  (2.5)
Postoperative: 2 months Number Analyzed 28 participants 27 participants
0.4  (0.8) 0.5  (0.8)
Postoperative: 6 months Number Analyzed 23 participants 28 participants
0.1  (0.8) 0.4  (0.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.66
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
5.Secondary Outcome
Title Neuropathic Pain Symptom Inventory
Hide Description Pain was assessed 2 days, and 2 and 6 months after surgery using a validated questionnaire to assess the degree of neuropathic characteristics of pain. This is termed the Neuropathic Pain Symptom Inventory which is scored 0-100 with 100 being the worst possible pain.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects were missed to follow up at different times
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description:
ketorolac tromethamine opthalmic solution 2 mg added to the patient's routine spinal anesthetic for surgery
sterile saline placebo added to the patient's routine spinal anesthetic for surgery
Overall Number of Participants Analyzed 28 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Postoperative: 2 days Number Analyzed 28 participants 29 participants
13  (13) 21  (14)
Postoperative: 2 months Number Analyzed 28 participants 27 participants
2.9  (4.6) 4.5  (7.2)
Postoperative: 6 months Number Analyzed 23 participants 28 participants
2.4  (6.6) 1.4  (3.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ketorolac, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.83
Comments [Not Specified]
Method ANOVA
Comments Repeated measures ANOVA
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketorolac Placebo
Hide Arm/Group Description

ketorolac 2 mg

ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery

placebo will be added to the patient's routine spinal anesthetic for surgery

placebo: placebo will be added to the patient's routine spinal anesthetic for surgery

All-Cause Mortality
Ketorolac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ketorolac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketorolac Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)   0/29 (0.00%) 
The trial was terminated because the study drug became unavailable.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. James C. Eisenach
Organization: Wake Forest School of Medicine
Phone: 336-716-4498
EMail: jimeisenach@gmail.com
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences ( Wake Forest University )
ClinicalTrials.gov Identifier: NCT00621530     History of Changes
Other Study ID Numbers: IRB00004736
5R37GM048085 ( U.S. NIH Grant/Contract )
First Submitted: February 11, 2008
First Posted: February 22, 2008
Results First Submitted: June 1, 2015
Results First Posted: July 27, 2017
Last Update Posted: September 11, 2018