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

NCT00993798 | Completed Phase 2 Results

• 1 other identifier: BU-002-IM
• Study Type: interventional
• Target: 107
• Locations: 5 countries
• Sites: 10

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.

Conditions

Postoperative Pain

Keywords

Post operative pain; Local anaesthesia; Postoperative pain after arthroscopic shoulder surgery

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (PI)

  Mean pain intensity on movement AUC (time-normalized AUC) during the period 0-3 days after surgery. Pain intensity was assessed with a standard 0 to 10 numeric rating scale (NRS), where no pain at all was rated as 0 and the worst pain imaginable was rated as 10. The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.

  0-3 days after surgery

• Supplemental Opioid Use

  Cumulative IV morphine-equivalent dose of opioid rescue medication

  0-3 days after surgery

Secondary Outcomes (2)

• Time to First Opioid Rescue Medication Usage

  0-14 days after surgery

• Opioid Related Side Effects

  0-7 days after surgery

Study Arms (6)

SABER-Bupivacaine Treatment 1a

EXPERIMENTAL

double-blind

Drug: SABER-Bupivacaine Treatment 1a

Placebo SABER-Bupivacaine Treatment 1b

PLACEBO COMPARATOR

double-blind

Drug: Placebo SABER-Bupivacaine Treatment 1b

Bupivacaine HCl Treatment 1c

ACTIVE COMPARATOR

double-blind

Drug: Bupivacaine HCl Treatment 1c

SABER-Bupivacaine Treatment 2a

EXPERIMENTAL

double-blind

Drug: SABER-Bupivacaine Treatment 2a

Placebo SABER-Bupivacaine Treatment 2b

PLACEBO COMPARATOR

double-blind

Drug: Placebo SABER-Bupivacaine Treatment 2b

Bupivacaine HCl Treatment 2c

ACTIVE COMPARATOR

double-blind

Drug: Bupivacaine HCl Treatment 2c

Interventions

SABER-Bupivacaine Treatment 1a DRUG

5.0 ml

Also known as: POSIMIR® bupivacaine solution

SABER-Bupivacaine Treatment 1a

Placebo SABER-Bupivacaine Treatment 1b DRUG

5.0 ml

Placebo SABER-Bupivacaine Treatment 1b

Bupivacaine HCl Treatment 1c DRUG

20.0 ml

Bupivacaine HCl Treatment 1c

SABER-Bupivacaine Treatment 2a DRUG

7.5 ml

SABER-Bupivacaine Treatment 2a

Placebo SABER-Bupivacaine Treatment 2b DRUG

7.5 ml

Placebo SABER-Bupivacaine Treatment 2b

Bupivacaine HCl Treatment 2c DRUG

20.0 ml

Bupivacaine HCl Treatment 2c

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Durect: lead
• Nycomed: collaborator

Study Sites (10)

Nycomed Investigational Site

Graz, Austria

Location

Nycomed Investigational Site

Vienna, 1090, Austria

Location

Nycomed Investigational Site

Vienna, 1130, Austria

Location

Nycomed Investigational Site

Berlin, Germany

Location

Nycomed Investigational Site

Dresden, Germany

Location

Nycomed Investigational Site

Marburg, Germany

Location

Nycomed Investigational Site

Riga, Latvia

Location

Nycomed Investigational Site

Valmiera, Latvia

Location

Nycomed Investigational Site

Lodz, Poland

Location

Nycomed Investigational Site

Stockholm, Sweden

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Deborah Scott
• Organization: Durect Corporation

deborah.scott@durect.com

408-777-1417

Study Officials

• Nycomed Clinical Trial Operations

  Headquarters

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2009
• First Posted: October 12, 2009
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: November 1, 2011
• Last Updated: June 9, 2021
• Results First Posted: June 9, 2021

Record last verified: 2021-05

Locations

AU (3); PL (1); SE (1); LA (2); DE (3)