Postoperative Analgesia After Shoulder Replacement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003860
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : October 29, 2009
Information provided by:
Thomas Jefferson University

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

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 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 : June 2006
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

0.5% Ropivicaine (150 mg)
0.75% Ropivicaine (225 mg)

Primary Outcome Measures :
  1. Amount of PCA morphine used by pt [ Time Frame: for 24 hours following surgery ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

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 identifier (NCT number): NCT01003860

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

Responsible Party: Dean Steinberg, M.D., Thomas Jefferson University Identifier: NCT01003860     History of Changes
Other Study ID Numbers: PCOM2009-01
First Posted: October 29, 2009    Key Record Dates
Last Update Posted: October 29, 2009
Last Verified: October 2009

Keywords provided by Thomas Jefferson University:
postoperative analgesia