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Trial record 3 of 128 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Injuries"

Ultrasound Guided Local Infiltration Analgesia for Hip Arthroscopy

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ClinicalTrials.gov Identifier: NCT01907191
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Saint Francis Care

Brief Summary:
This study is being undertaken to compare the pain control using either bupivacaine versus liposomal bupivacaine. Liposomal bupivacaine can potentially provide pain relief lasting up to 72 hours while regular bupivacaine can provide pain relief up to 12 hours

Condition or disease Intervention/treatment Phase
Hip Injuries Drug: liposomal bupivacaine Drug: Bupivacaine Not Applicable

Detailed Description:
Patients undergoing hip arthroscopy experience moderate to severe postoperative pain. Effective pain control after surgery is an important component in the overall management of these patients. Good pain control encourages early participation in rehabilitation program, increases success of the surgery, and improves patient satisfaction. Typically, postoperative analgesia is provided to these patients either with nerve blocks or opioid medications. Both these methods provide good pain relief but nerve blocks are associated with weakness of lower extremity muscles which interferes with early ambulation and increase the risk of falls while narcotic medications increase the risk of nausea, vomiting, itching, constipation, ileus, urinary retention, sedation and respiratory depression.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Bupivacaine to Liposomal Bupivacaine for Ultrasound Guided Periarticular Hip Infiltration for Postoperative Analgesia After Hip Arthroscopy.
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liposomal bupivacaine
Ultrasound guided injection of liposomal bupivacaine
Drug: liposomal bupivacaine
(Ultrasound guided injection of liposomal bupivacaine)
Other Name: Exparel

Active Comparator: Bupivacaine
Bupivacaine (around the anterior, lateral and medial aspect of hip joint)
Drug: Bupivacaine
(around the anterior, lateral and medial aspect of hip joint)
Other Name: Marcaine




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 96 hours after surgery ]
    Opioid consumption will be reviewed at 96 hours after surgery.


Secondary Outcome Measures :
  1. Pain Scores [ Time Frame: 96 hours after surgery ]
    Analysis of pain scores (at rest and ambulation) during hospital stay.


Other Outcome Measures:
  1. Sleep disturbance [ Time Frame: 96 hours after surgery ]
    Analysis of sleep disturbance during hospital stay

  2. Satisfaction with pain management [ Time Frame: 96 hours after surgery ]
    Analysis of pain management satisfaction during hospital stay



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having hip arthroscopy

Exclusion Criteria:

  • History of neurologic disease, neuropathy, diabetes
  • Allergy to local anesthetic solution
  • Chronic use of narcotics
  • Inability to give consent/cooperate with study
  • History of previous hip arthroscopy on the ipsilateral side
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907191


Contacts
Contact: Sanjay Sinha, MD sanjaysinha@comcast.net

Locations
United States, Connecticut
Saint Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
Contact: Sanjay Sinha, MD       sanjaysinha@comcast.net   
Principal Investigator: Sanjay Sinha, MD         
Sponsors and Collaborators
Saint Francis Care
Investigators
Principal Investigator: Sanjay Sinha, MD Saint Francis Hospital and Medical Center

Responsible Party: Saint Francis Care
ClinicalTrials.gov Identifier: NCT01907191     History of Changes
Other Study ID Numbers: 13-06-001
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Saint Francis Care:
Hip Arthroscopy
Liposomal Bupivacaine
Bupivacaine

Additional relevant MeSH terms:
Hip Injuries
Wounds and Injuries
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents