Management of Postoperative Pain After Total Knee Replacement.

NCT01163214 | Completed Phase 4 Results

• 2 other identifiers: 10-003312UL1TR000135
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two methods of postoperative pain management in patients undergoing total knee replacement.

Conditions

Postoperative Pain; Knee Replacement Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pain

  Pain was measured using a linear analog scale for pain, with a scale from 0 (no pain) to 10 points (worst possible pain).

  Afternoon on post-operative Day 1, approximately 14:00

Secondary Outcomes (5)

• Pain Scores in the Per-protocol Subset (Participants Who Received the Allocated Treatment)

  Afternoon on post-operative Day 1, approximately 14:00

• Narcotic Use

  Intraoperative, Day of surgery, Post-Operative Day 1, Post-Operative Day 2

• Straight-leg Raise

  Day 1 morning (AM), Day 1 afternoon (PM), Day 2 morning, Day 2 afternoon

• Length of Stay in Hospital

  Approximately 2 days after surgery

• Number of Subjects Who Experienced Neurological Changes Postoperatively

  6 weeks postoperative

Study Arms (2)

Nerve Block

EXPERIMENTAL

Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.

Drug: Nerve Block

Periarticular Injection

ACTIVE COMPARATOR

Injection combination prior to skin closure.

Drug: Periarticular Injection

Interventions

Nerve Block DRUG

Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.

Also known as: Naropin

Nerve Block

Periarticular Injection DRUG

Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.

Also known as: Naropin, Adrenalin, Toradol

Periarticular Injection

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral primary total knee replacement.
• Weight 50-125 kg.
• Age 18-79 years.
• Intact neurological exam to the surgical lower extremity.
• Cognitively intact with ability to sign informed consent.

You may not qualify if:

• Renal insufficiency with creatinine \>1.5 mg/dL.
• Allergy to medication used in the study.
• Using narcotic medication prior to surgery (morphine equivalents \>=20 mg/day for \>7 days.)
• Prior open knee surgery with regional anesthesia or periarticular injection for post-operative pain management.

Sponsors & Collaborators

• Mark J. Spangehl, M.D.: lead

Study Sites (1)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Related Publications (1)

• Spangehl MJ, Clarke HD, Hentz JG, Misra L, Blocher JL, Seamans DP. The Chitranjan Ranawat Award: Periarticular injections and femoral & sciatic blocks provide similar pain relief after TKA: a randomized clinical trial. Clin Orthop Relat Res. 2015 Jan;473(1):45-53. doi: 10.1007/s11999-014-3603-0.

  PMID: 24706022 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nerve Block; Ropivacaine; Epinephrine; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Participants and staff could not be blinded to the treatment arm received; participants' pain was evaluated at rest and not with activity; the study was not powered to identify certain rare events such as falls.

Results Point of Contact

• Title: Mark J. Spangehl, M.D.
• Organization: Mayo Clinic

spangehl.mark@mayo.edu

480-342-2377

Study Officials

• Mark J Spangehl, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Orthopedics

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 5, 2014
• Results First Posted: November 5, 2014

Record last verified: 2014-11

Locations

US (1)