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

Phase 2

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine HCl Treatment 1c; Drug: SABER-Bupivacaine Treatment 2a; Drug: Placebo SABER-Bupivacaine Treatment 2b; Drug: SABER-Bupivacaine Treatment 1a; Drug: Bupivacaine HCl Treatment 2c; Drug: Placebo SABER-Bupivacaine Treatment 1b

• Registration Number: NCT00993798
• Lead Sponsor: Durect

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-10-09
• Study First Submitted QC: 2009-10-09
• Study First Posted: 2009-10-12
• Primary Completion: 2011-06
• Study Completion: 2011-11
• Disposition First Submitted: 2013-01-23
• Disposition First Submitted QC: 2013-01-23
• Disposition First Posted: 2013-01-29
• Results First Submitted: 2021-03-01
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-13
• Last Update Submitted: 2021-05-13
• Results First Posted: 2021-06-09
• Last Update Posted: 2021-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine HCl Treatment 1c	Bupivacaine HCl Treatment 1c	double-blind
SABER-Bupivacaine Treatment 2a	SABER-Bupivacaine Treatment 2a	double-blind
Placebo SABER-Bupivacaine Treatment 2b	Placebo SABER-Bupivacaine Treatment 2b	double-blind
SABER-Bupivacaine Treatment 1a	SABER-Bupivacaine Treatment 1a	double-blind
Bupivacaine HCl Treatment 2c	Bupivacaine HCl Treatment 2c	double-blind
Placebo SABER-Bupivacaine Treatment 1b	Placebo SABER-Bupivacaine Treatment 1b	double-blind

Primary Outcome Measures

Name	Time	Method
Pain Intensity (PI)	0-3 days after surgery	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.
Supplemental Opioid Use	0-3 days after surgery	Cumulative IV morphine-equivalent dose of opioid rescue medication

Secondary Outcome Measures

Name	Time	Method
Opioid Related Side Effects	0-7 days after surgery	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.
Time to First Opioid Rescue Medication Usage	0-14 days after surgery

Trial Locations

Locations (1)

Nycomed Investigational Site; 🇸🇪 Stockholm, Sweden