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

Purpose

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	Intervention	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 Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

Drug Information available for: Bupivacaine hydrochloride Bupivacaine

U.S. FDA Resources

Further study details as provided by Durect:

Primary Outcome Measures:

Pain intensity (PI) [ Time Frame: 0-3 days after surgery ] [ Designated as safety issue: No ]
Supplemental opioid use [ Time Frame: 0-3 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to first opioid rescue medication usage [ Time Frame: 0-14 days after surgery ] [ Designated as safety issue: No ]
Frequency of opioid related side effects [ Time Frame: 0-7 days after surgery ] [ Designated as safety issue: No ]

Enrollment:	107
Study Start Date:	April 2009
Study Completion Date:	November 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

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

Nycomed: A Takeda Company

Investigators

Study Chair:

Nycomed Clinical Trial Operations

Headquarters

More Information

No publications provided

Responsible Party:	Durect
ClinicalTrials.gov Identifier:	NCT00993798 History of Changes
Other Study ID Numbers:	BU-002-IM
Study First Received:	October 9, 2009
Last Updated:	January 30, 2013
Health Authority:	Austria: Federal Office for Safety in Health Care Denmark: Danish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Latvia: State Agency of Medicines Poland: The Central Register of Clinical Trials Sweden: Medical Products Agency

Keywords provided by Durect:

Post operative pain
Local anaesthesia
Postoperative pain after arthroscopic shoulder surgery

Additional relevant MeSH terms:

Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013