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

Primary Purpose

Hip Arthroplasty

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ketorolac tromethamine opthalmic solution

placebo

About this trial

This is an interventional treatment trial for Hip Arthroplasty focused on measuring Total hip arthroplasty, Total hip replacement, Pain, postoperative, Ketorolac, Patients undergoing unilateral total hip arthroplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

American Society of Anesthesiologists (ASA) physical status I, II, III
> Age 18
Primary unilateral total hip arthroplasty under spinal anesthesia

Exclusion Criteria:

Known allergy to study medication
Weight > 300 pounds
Obstructive sleep apnea
Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia
Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure
Patients routinely taking narcotic pain medications for pain other than their primary hip pain
Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures

Sites / Locations

Wake Forest University Baptist Medical Center
The Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketorolac

Placebo

Arm Description

ketorolac 2 mg ketorolac tromethamine opthalmic solution

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

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.

Full Information

NCT ID

NCT00621530

First Posted

February 11, 2008

Last Updated

August 13, 2018

Sponsor

Wake Forest University

Collaborators

National Institute of General Medical Sciences (NIGMS)

1. Study Identification

Unique Protocol Identification Number

NCT00621530

Brief Title

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

Official Title

Effect of Intrathecal Ketorolac on Mechanical Hypersensitivity After Total Hip Arthroplasty

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Terminated

Why Stopped

Terminated due to discontinuation of Acular PF (investigational medication)

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University

Collaborators

National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Arthroplasty

Keywords

Total hip arthroplasty, Total hip replacement, Pain, postoperative, Ketorolac, Patients undergoing unilateral total hip arthroplasty

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ketorolac

Arm Type

Experimental

Arm Description

ketorolac 2 mg ketorolac tromethamine opthalmic solution

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ketorolac tromethamine opthalmic solution

Other Intervention Name(s)

Acular- Preservative Free (PF), Ketorolac

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Area of Hypersensitivity to Mechanical Stimuli Surrounding the Wound 48 Hours After Surgery

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

Secondary Outcome Measure Information:

Title

Present Pain Intensity

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

Title

McGill Pain Intensity

Description

Time Frame

6 months

Title

McGill Affective Pain

Description

Time Frame

6 months

Title

Neuropathic Pain Symptom Inventory

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I, II, III > Age 18 Primary unilateral total hip arthroplasty under spinal anesthesia Exclusion Criteria: Known allergy to study medication Weight > 300 pounds Obstructive sleep apnea Patients with severe renal (kidney) or hepatic (liver) disease, allergy to ketorolac, amino amide local anesthetic, or contraindications to spinal anesthesia Patients on dialysis for kidney failure or patients that are jaundice or have a diagnosis of liver failure Patients routinely taking narcotic pain medications for pain other than their primary hip pain Patients that are taking Lyrica (pregabalin) or Gabapentin (neurontin) for the treatment of seizures

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James C. Eisenach, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

The Cleveland Clinic Foundation

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44120

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24535482

Citation

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.

Results Reference

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

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