Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion

NCT01108562 | Withdrawn Phase 1 DMC

• 1 other identifier: 57366
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.

Conditions

Postoperative Pain Management After Total Hip Arthroplasty

Keywords

postoperative pain management

Outcome Measures

Primary Outcomes (1)

• We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia.

  24 hours

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline.

Other: Normal Saline

Lidocaine Group

EXPERIMENTAL

Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion.

Drug: Lidocaine

Interventions

Lidocaine DRUG

Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.

Lidocaine Group

Normal Saline OTHER

Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking

You may not qualify if:

• Age \> 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment

Sponsors & Collaborators

• Loma Linda University: lead
• Charles Lee MD: collaborator
• Michelle Schlunt MD: collaborator

MeSH Terms

Interventions

Lidocaine; Saline Solution

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Michelle L Schlunt, MD

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: April 22, 2010
• Study Start: February 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: April 6, 2015

Record last verified: 2015-04