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Postoperative Analgesia After Shoulder Replacement

Sponsor
Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT01003860
Collaborator
(none)
39
Enrollment
1
Location
10
Duration (Months)
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A comparison was made regarding opioid analgesic usage immediately after elective shoulder replacement and for seven days at home between patients randomly given either 0.5% or 0.75% ropivacaine via interscalene block prior to surgery.

It is hypothesized that no significant difference will exist between both groups with respect to pain medication used in the hospital and for a 7-day period at home.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    After IRB approval, 46 patients undergoing elective shoulder replacement surgery were recruited at Methodist Hospital (Philadelphia) for this single blind, randomized pilot study. Consented patients spent 48 hours in-house. They were randomly given either 0.5% or 0.75% ropivacaine via interscalene block (ISB) prior to surgery. After the operation, patients were transferred to the post anesthesia care unit (PACU) and placed on a patient controlled analgesia (PCA) morphine pump: basal rate of 0 mg; bolus of 1 mg; lock-out period of 10 min (maximum dose of 6 mg/hr). If the PCA did not provide adequate analgesia, subjects could also receive a bolus of morphine, 2 to 4 mg i.v., every fifteen minutes for several doses p.r.n. In addition, parameters of the PCA could also be modified in order to allow for increased delivery of morphine (e.g., lock-out of 6 min w/max dose of 10 mg/hr) for patient analgesia. PCA morphine therapy was continued after patient was transferred from the PACU to the patient's recovery room. PCA morphine therapy was discontinued the day after surgery and patients were given oral Percocet tablets for pain management. . Thirty-nine patients successfully completed this part of the study. There was no significant difference (p>0.05) between groups in amount of post-operative medications consumed (PCA morphine and oral analgesics) or post-operative pain.

    Upon release, patients were given pain and medication diaries to complete for seven successive days. All patients recorded the total amount of Percocet tablets taken at home each day in addition to pain scores (0-10) in the morning, afternoon and evening. Twenty-seven patients successfully completed this part of the study. There was no significant difference (p>0.05)between groups in regard to pain; however, patients in the higher 0.75% group unexpectedly took more tablets (p<0.05).

    Conclusion: The 0.5% ISB dose of ropivacaine was found to be equally efficacious as 0.75%; since this lower concentration would also reduce the risk of serious systemic toxicity, it is recommended for ISB prior to elective shoulder replacement.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    39 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison Of 0.5% Vs. 0.75% Ropivacaine Interscalene Brachial Plexus Block (ISB) Prior To Elective Total Shoulder Replacement Surgery On Use of Analgesic Medication During Post-Discharge Week
    Study Start Date :
    Jun 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2007
    Actual Study Completion Date :
    Apr 1, 2007

    Arms and Interventions

    Arm Intervention/Treatment
    0.5% Ropivicaine (150 mg)
    0.75% Ropivicaine (225 mg)

    Outcome Measures

    Primary Outcome Measures

    1. Amount of PCA morphine used by pt [for 24 hours following surgery]

    Secondary Outcome Measures

    1. Amt of analgesic medication used daily at home for 7 days after discharge from hospital [recorded for 7 days at home following discharge from hospital]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • patients undergoing total shoulder replacement surgery

    • 18 years of age or older

    • expected length of stay of at least 24 hours

    • able to report pain levels

    • able to request medications as needed

    • American Society of Anesthesiologist (ASA) physical status classification of P1 or P2

    Exclusion Criteria:

    • liver disease

    • kidney disease

    • antidepressant therapy (e.g., for clinical depression and/ or chronic pain syndrome)

    • ASA physical status classification of P3 or higher

    • pregnancy

    • allergy to any medications used to treat patient

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Methodist Hospital Philadelphia Pennsylvania United States 19148

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    • Principal Investigator: Dean Steinberg, MD, Thomas Jefferson University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01003860
    Other Study ID Numbers:
    • PCOM2009-01
    First Posted:
    Oct 29, 2009
    Last Update Posted:
    Oct 29, 2009
    Last Verified:
    Oct 1, 2009
    Keywords provided by , ,
    postoperative analgesia
    Additional relevant MeSH terms:
    Agnosia

    Study Results

    No Results Posted as of Oct 29, 2009