Postoperative Analgesia After Shoulder Replacement

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01003860
First received: October 28, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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
Analgesia

Study Type: Observational
Study Design: 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

Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Amount of PCA morphine used by pt [ Time Frame: for 24 hours following surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amt of analgesic medication used daily at home for 7 days after discharge from hospital [ Time Frame: recorded for 7 days at home following discharge from hospital ] [ Designated as safety issue: No ]

Enrollment: 39
Study Start Date: June 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
0.5% Ropivicaine (150 mg)
0.75% Ropivicaine (225 mg)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Male and female patients undergoing shoulder replacement surgery at Methodist Hospital. Ethnicities and ages of patients varied.

Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01003860

Locations
United States, Pennsylvania
Methodist Hospital
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Dean Steinberg, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Dean Steinberg, M.D., Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01003860     History of Changes
Other Study ID Numbers: PCOM2009-01
Study First Received: October 28, 2009
Last Updated: October 28, 2009
Health Authority: United States: Federal Government

Keywords provided by Thomas Jefferson University:
postoperative analgesia

ClinicalTrials.gov processed this record on October 16, 2014