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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993798
• Other study ID #: BU-002-IM
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: November 2011

Study information

• Verified date: May 2021
• Source: Durect
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: November 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• SABER-Bupivacaine Treatment 1a
5.0 ml
• Placebo SABER-Bupivacaine Treatment 1b
5.0 ml
• Bupivacaine HCl Treatment 1c
20.0 ml
• SABER-Bupivacaine Treatment 2a
7.5 ml
• Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
• Bupivacaine HCl Treatment 2c
20.0 ml

Locations

Country	Name	City	State
Austria	Nycomed Investigational Site	Graz
Austria	Nycomed Investigational Site	Vienna
Austria	Nycomed Investigational Site	Vienna
Germany	Nycomed Investigational Site	Berlin
Germany	Nycomed Investigational Site	Dresden
Germany	Nycomed Investigational Site	Marburg
Latvia	Nycomed Investigational Site	Riga
Latvia	Nycomed Investigational Site	Valmiera
Poland	Nycomed Investigational Site	Lodz
Sweden	Nycomed Investigational Site	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Durect	Nycomed

Countries where clinical trial is conducted

Austria,  Germany,  Latvia,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Supplemental Opioid Use	Cumulative IV morphine-equivalent dose of opioid rescue medication	0-3 days after surgery
Secondary	Time to First Opioid Rescue Medication Usage		0-14 days after surgery
Secondary	Opioid Related Side Effects	Opioid-related side effects were recorded 0-7 days after surgery. The Opioid-Related Symptom Distress Scale (OR-SDS) is a composite score computed from a questionnaire containing frequent opioid-related symptoms (Fatigue, Drowsiness, Inability to concentrate, Nausea, Dizziness, Constipation, Itching, Difficulty with urination, Confusion, Retching/vomiting). For each symptom, patients assigned integer scores to assess severity (none=0 to very severe=4), bothersomeness (none=0 to very much=5), and frequency (none=0 to almost constantly=4); patients reported number of Retching/vomiting episodes (none=0, 1-2 episodes=1, 3-4 episodes=2, 5-6 episodes=3, >6 episodes=4).; On each day (Day 0-7), the score for each symptom was the mean of the three component scores, and the OR-SDS score was the overall mean of the 10 symptom scores, (values from 0 to 4; larger outcomes are worse). The mean of the daily OR-SDS score from Day 0 to 7 gave the overall OR-SDS Score.	0-7 days after surgery