Ketorolac Effects on Post-operative Pain and Bone Healing

NCT01133639 | Terminated Results

• 1 other identifier: 2010P000047
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.

Conditions

Bunion

Outcome Measures

Primary Outcomes (2)

• Post-Operative Pain

  18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.

  Post-Operative Day 2

• Osseous Healing

  Radiographic assessment by a blinded board certified radiologist

  3 months

Secondary Outcomes (3)

• Post-operative Activity Recovery

  up to 3 months

• Adverse Events

  1 week

• Quantity of Narcotic Medication

  1 week

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo plus standard of care

Drug: Placebo

Ketorolac

EXPERIMENTAL

30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care

Drug: Ketorolac

Interventions

Ketorolac DRUG

30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care

Ketorolac

Placebo DRUG

Placebo plus standard of care

Placebo

Eligibility Criteria

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

You may qualify if:

• Hallux abductus with bunion deformity
• Adult patients as defined by \>=18 years old and \<= 65 years old
• Subject has adequate perfusion, verified by the surgeon, which is defined by palpable pedal pulses
• Subject has voluntarily signed and dated an informed consent form, approved by IRB, and provided HIPAA (or other applicable privacy regulation) authorization prior to any participation in the study
• Subject agrees not to take any new medications, dietary supplements, or alternative therapies during the study period (approximately 12 weeks)
• Subject is interested in participating in the study and willing to comply with the study protocol
• Patient has pain related to a bunion deformity but pain-free metatarsalphalangeal joint (MTPJ) range of motion that is not functionally adapted
• Adequate bone density to withstand a Kalish bunionectomy procedure
• No frontal plane hallux deformity
• Minimal abnormality of the PASA
• Normal to minimally malaligned sagittal plane position of the first metatarsal
• Failure of conservative treatment
• General Pre-operative Radiographic Angle Criteria† - 10-15 degree IMA in rectus feet\* - 20-25 degree TAA in adducted feet\* - 15-20 degree IMA in rectus feet if wide metatarsal head width - 25-30 degree TAA in adducted feet if wide metatarsal head width IMA=intermetatarsal angle; TAA=total adductus angle \*If the pre-operative IMA is \<15 degree, only the IMA will be used pre-operatively. For IMA \>=15, the total adductus angle will be used †These are general guidelines and the width of the metatarsal as well as the presence of positional, structural, or combined first ray deformity may also influence procedure selection.

You may not qualify if:

• a history of an allergic-type reaction in response to exposure to aspirin, phenylacetic acid derivatives, or other NSAIDs
• hypersensitivity to ketorolac tromethamine, or to any product component
• any known bleeding risk or bleeding disorder, suspected or confirmed
• history of or active cerebrovascular bleeding, suspected or confirmed
• concomitant aspirin or NSAID use where the patient may not be advised to discontinue the medication during the study
• concomitant pentoxifylline use
• concomitant probenecid use
• coronary artery bypass graft (CABG) surgery within one year of the procedure
• any history of gastrointestinal bleeding/perforation, gastrointestinal ulcer, severe peptic ulcer disease, or severe inflammatory bowel disease
• hemorrhagic diathesis, suspected or confirmed
• incomplete intraoperative hemostasis
• pre-operative serum creatinine \> 1.5 ml/dL or blood urea nitrogen level \> 22 mg/dL
• any history of renal impairment or risk of renal failure due to volume depletion
• Patients with a known allergy, contraindication and/or intolerance for oxycodone 5mg - acetaminophen 325 mg will be excluded from the study.
• Patients with a known allergy, contraindication, and/or intolerance for the local anesthetic (bupivicaine) or any of the standardized intra-operative opioids and anti-emetics administered by the anesthesiologist

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• American College of Foot and Ankle Surgeons: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Bunion

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Emily Cook
• Organization: Mount Auburn

ecook@mah.harvard.edu

(617) 354-3131

Study Officials

• Emily A Cook, DPM, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Surgery

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 31, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: August 21, 2019
• Results First Posted: October 17, 2018

Record last verified: 2019-08

Locations

US (1)