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| ID | Type | Description | Link |
|---|---|---|---|
| 5R37GM048085 | U.S. NIH Grant/Contract | View source |
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Terminated due to discontinuation of Acular PF (investigational medication)
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| Name | Class |
|---|---|
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Chronic pain in patients following total hip replacement seems to be a significant problem. Previous research has shown that more effective pain management in the early postoperative period may decrease the incidence of the development of chronic pain states.
This study will evaluate whether ketorolac (a non steroidal anti-inflammatory drug) given into the spinal fluid before surgery will reduce the area of sensitivity (or pain to light touch) following surgery. Patients will be monitored during their postoperative hospital stay and then contacted by telephone at 8 weeks and 6 months after surgery and questioned about any pain they are having at their surgical site. Patients that are still experiencing pain at 6 months will be asked to return to the medical center for the study staff to assess their pain or sensitivity at the surgical site.
Surgery results in hypersensitivity to mechanical stimuli surrounding the wound and in a subset of patients, also results in chronic pain. The purpose of the study is to test whether intrathecal ketorolac, by selectively and effectively blocking cyclooxygenase in the spinal cord, will reduce hypersensitivity surrounding the surgical wound in patients with high risk for developing chronic pain after surgery. We have chosen to study patients having total hip arthroplasty (THA) because chronic pain seems to be a significant problem after surgery. We will sample cerebrospinal fluid (CSF) prior to injection of the study medication for subsequent prostaglandin E2 (PGE2) analysis in each patient. We will also assess each patient at 48 hours after their surgery for hypersensitivity at their surgical site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | ketorolac 2 mg ketorolac tromethamine opthalmic solution |
|
| Placebo | Placebo Comparator | placebo will be added to the patient's routine spinal anesthetic for surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketorolac tromethamine opthalmic solution | Drug | ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery | Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Present Pain Intensity | 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 | 6 months |
| McGill Pain Intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C. Eisenach, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24535482 | Derived | Wang L, Bauer M, Curry R, Larsson A, Sessler DI, Eisenach JC. Intrathecal ketorolac does not improve acute or chronic pain after hip arthroplasty: a randomized controlled trial. J Anesth. 2014 Oct;28(5):790-3. doi: 10.1007/s00540-014-1798-6. Epub 2014 Feb 18. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery | Hyperalgesia (using a von Frey filament) and allodynia (using a cotton swab) were evaluated around the surgical site 48 hours after surgery. | These are data from the 57 subjects who remained in the study at the time of the primary outcome measure 48 hr after surgery | Posted | Median | Full Range | area in centimeters squared | 48 hours |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac | ketorolac 2 mg ketorolac tromethamine opthalmic solution: ketorolac 2 mg will be added to the patient's routine spinal anesthetic for surgery |
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The trial was terminated because the study drug became unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. James C. Eisenach | Wake Forest School of Medicine | 336-716-4498 | jimeisenach@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 24, 2011 | Jul 28, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2009 | Jul 28, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| placebo | Drug | placebo will be added to the patient's routine spinal anesthetic for surgery |
|
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.
| 6 months |
| McGill Affective Pain | 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. | 6 months |
| Neuropathic Pain Symptom Inventory | 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. | 6 months |
| The Cleveland Clinic Foundation |
| Cleveland |
| Ohio |
| 44120 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Secondary | Present Pain Intensity | 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 | Some subjects were missed to follow up at different times | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | McGill Pain Intensity | 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. | Some subjects were missed to follow up at different times | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | McGill Affective Pain | 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. | Some subjects were missed to follow up at different times | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| Secondary | Neuropathic Pain Symptom Inventory | 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. | Some subjects were missed to follow up at different times | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | 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 | 0 | 29 | 0 | 29 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| Postoperative: 2 days |
|
|
| Postoperative: 2 months |
|
|
| Postoperative: 6 months |
|
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| Postoperative: 2 months |
|
|
| Postoperative: 6 months |
|
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| Postoperative: 2 months |
|
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| Postoperative: 6 months |
|
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| Postoperative: 2 months |
|
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| Postoperative: 6 months |
|
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