Trial Outcomes & Findings for Effect of Spinal Ketorolac on Mechanical Hypersensitivity After a Total Hip Replacement (NCT NCT00621530)

Results Overview

Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

62 participants

Primary outcome timeframe

48 hours

Results posted on

2018-09-11

Participant Flow

Participant milestones

Participant milestones
Measure	Ketorolac ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg 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 placebo: placebo will be added to the patient's routine spinal anesthetic for surgery
Overall Study STARTED	30	32
Overall Study COMPLETED	28	29
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=30 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=32 Participants 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 n=62 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	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	17 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	32 participants n=7 Participants	62 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery

Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery.

Outcome measures

Outcome measures
Measure	Ketorolac n=28 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=29 Participants 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
Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery	0 area in centimeters squared Interval 0.0 to 84.0	0 area in centimeters squared Interval 0.0 to 49.0

SECONDARY outcome

Timeframe: 6 months

Population: Some subjects were missed to follow up at different times

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

Outcome measures

Outcome measures
Measure	Ketorolac n=28 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=29 Participants 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
Present Pain Intensity Preoperative	1.7 units on a scale Standard Deviation 1.5	1.6 units on a scale Standard Deviation 1.1
Present Pain Intensity Postoperative: 2 days	2.1 units on a scale Standard Deviation 1.8	2.5 units on a scale Standard Deviation 2.3
Present Pain Intensity Postoperative: 2 months	0.6 units on a scale Standard Deviation 1.2	0.2 units on a scale Standard Deviation 0.3
Present Pain Intensity Postoperative: 6 months	0.4 units on a scale Standard Deviation 0.6	0.1 units on a scale Standard Deviation 0.2

SECONDARY outcome

Timeframe: 6 months

Population: Some subjects were missed to follow up at different times

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=28 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=29 Participants 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
McGill Pain Intensity Postoperative: 2 days	11 units on a scale Standard Deviation 6.3	10 units on a scale Standard Deviation 6.6
McGill Pain Intensity Postoperative: 2 months	2.3 units on a scale Standard Deviation 3.3	3.1 units on a scale Standard Deviation 4.1
McGill Pain Intensity Postoperative: 6 months	1.4 units on a scale Standard Deviation 3.8	1.2 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 6 months

Population: Some subjects were missed to follow up at different times

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=28 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=29 Participants 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
McGill Affective Pain Postoperative: 2 days	2.3 units on a scale Standard Deviation 2.5	2.3 units on a scale Standard Deviation 2.5
McGill Affective Pain Postoperative: 2 months	0.4 units on a scale Standard Deviation 0.8	0.5 units on a scale Standard Deviation 0.8
McGill Affective Pain Postoperative: 6 months	0.1 units on a scale Standard Deviation 0.8	0.4 units on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months

Population: Some subjects were missed to follow up at different times

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.

Outcome measures

Outcome measures
Measure	Ketorolac n=28 Participants ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery	Placebo n=29 Participants 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
Neuropathic Pain Symptom Inventory Postoperative: 2 days	13 units on a scale Standard Deviation 13	21 units on a scale Standard Deviation 14
Neuropathic Pain Symptom Inventory Postoperative: 2 months	2.9 units on a scale Standard Deviation 4.6	4.5 units on a scale Standard Deviation 7.2
Neuropathic Pain Symptom Inventory Postoperative: 6 months	2.4 units on a scale Standard Deviation 6.6	1.4 units on a scale Standard Deviation 3.2

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. James C. Eisenach

Wake Forest School of Medicine

Phone: 336-716-4498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place