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

NCT00621530 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB000047365R37GM048085
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Hip Arthroplasty

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Present Pain Intensity

  6 months

• McGill Pain Intensity

  6 months

• McGill Affective Pain

  6 months

• Neuropathic Pain Symptom Inventory

  6 months

Study Arms (2)

Ketorolac

EXPERIMENTAL

ketorolac 2 mg ketorolac tromethamine opthalmic solution

Drug: ketorolac tromethamine opthalmic solution

Placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

ketorolac tromethamine opthalmic solution DRUG

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

Also known as: Acular- Preservative Free (PF), Ketorolac

Ketorolac

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (2)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44120, United States

Location

Related Publications (1)

• 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.

  PMID: 24535482 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The trial was terminated because the study drug became unavailable.

Results Point of Contact

• Title: Dr. James C. Eisenach
• Organization: Wake Forest School of Medicine

jimeisenach@gmail.com

336-716-4498

Study Officials

• James C. Eisenach, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 22, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: September 11, 2018
• Results First Posted: July 27, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)