An International Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery

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ClinicalTrials.gov Identifier: NCT00993798

Recruitment Status : Completed

First Posted : October 12, 2009

Last Update Posted : February 4, 2013

Sponsor:

Collaborator:

Takeda

Information provided by (Responsible Party):

Durect

Study Description

Brief Summary:

The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing elective arthroscopic shoulder surgery on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on safety.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Drug: SABER-Bupivacaine Treatment 1a Drug: Placebo SABER-Bupivacaine Treatment 1b Drug: Bupivacaine HCl Treatment 1c Drug: SABER-Bupivacaine Treatment 2a Drug: Placebo SABER-Bupivacaine Treatment 2b Drug: Bupivacaine HCl Treatment 2c	Phase 2

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	107 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery
Study Start Date :	April 2009
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	November 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: SABER-Bupivacaine Treatment 1a double-blind	Drug: SABER-Bupivacaine Treatment 1a 5.0 ml
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 1b double-blind	Drug: Placebo SABER-Bupivacaine Treatment 1b 5.0 ml
Active Comparator: Bupivacaine HCl Treatment 1c double-blind	Drug: Bupivacaine HCl Treatment 1c 20.0 ml
Experimental: SABER-Bupivacaine Treatment 2a double-blind	Drug: SABER-Bupivacaine Treatment 2a 7.5 ml
Placebo Comparator: Placebo SABER-Bupivacaine Treatment 2b double-blind	Drug: Placebo SABER-Bupivacaine Treatment 2b 7.5 ml
Active Comparator: Bupivacaine HCl Treatment 2c double-blind	Drug: Bupivacaine HCl Treatment 2c 20.0 ml

Outcome Measures

Primary Outcome Measures :

Pain intensity (PI) [ Time Frame: 0-3 days after surgery ]
Supplemental opioid use [ Time Frame: 0-3 days after surgery ]

Secondary Outcome Measures :

Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ]
Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subacromial impingement syndrome
MRI with intact rotator cuff
Patients suitable for general anaesthesia

Exclusion Criteria:

Known major joint trauma, infection, avascular necrosis, chronic dislocation, inflammatory or degenerative glenohumeral arthropathy, glenohumeral arthritis, frozen shoulder or previous surgery of the affected shoulder
Abnormal ECG
Prolonged QT syndrome
Current or regular use of analgesic medication for other indication(s)

Contacts and Locations

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): NCT00993798

Locations


Austria
Nycomed Investigational Site
Graz, Austria
Nycomed Investigational Site
Vienna, Austria, 1090
Nycomed Investigational Site
Vienna, Austria, 1130
Denmark
Nycomed Investigational Site
Skoerping, Denmark
Germany
Nycomed Investigational Site
Berlin, Germany
Nycomed Investigational Site
Dresden, Germany
Nycomed Investigational Site
Marburg, Germany
Latvia
Nycomed Investigational Site
Riga, Latvia
Nycomed Investigational Site
Valmiera, Latvia
Poland
Nycomed Investigational Site
Lodz, Poland
Sweden
Nycomed Investigational Site
Stockholm, Sweden

Sponsors and Collaborators

Durect

Takeda

Investigators


Study Chair:	Nycomed Clinical Trial Operations	Headquarters

More Information


Responsible Party:	Durect
ClinicalTrials.gov Identifier:	NCT00993798 History of Changes
Other Study ID Numbers:	BU-002-IM
First Posted:	October 12, 2009 Key Record Dates
Last Update Posted:	February 4, 2013
Last Verified:	January 2013

Keywords provided by Durect:


Post operative pain Local anaesthesia Postoperative pain after arthroscopic shoulder surgery

Additional relevant MeSH terms:


Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms	Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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