An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy

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 Undergoing Primary, Elective, Open, Abdominal Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00993226
• Other study ID #: BU-001-IM
• Status: Completed
• Phase: Phase 2
• Start date: May 2009
• Est. completion date: July 2010

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 hysterectomy 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 the efficacy and safety of the product.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: July 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• A planned elective, abdominal hysterectomy

• Patients suitable for general anaesthesia

Exclusion Criteria:

• Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities

• Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)

• 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
40 ml
• SABER-Bupivacaine Treatment 2a
7.5 ml
• Placebo SABER-Bupivacaine Treatment 2b
7.5 ml
• Bupivacaine HCl Treatment 2c
40 ml

Locations

Country	Name	City	State
France	Nycomed	Paris
Germany	Nycomed	Bayreuth
Germany	Nycomed	Dresden
Hungary	Nycomed	Békéscsaba
Hungary	Nycomed	Budapest
Hungary	Nycomed	Debrecen
Hungary	Nycomed	Györ
Hungary	Nycomed	Nyíregyháza
Hungary	Nycomed	Székesfehérvár
Hungary	Nycomed	Szolnok
Hungary	Nycomed	Tatabánya
Latvia	Nycomed	Riga
Sweden	Nycomed	Stockholm
United Kingdom	Nycomed	London

Sponsors (2)

Lead Sponsor	Collaborator
Durect	Nycomed

Countries where clinical trial is conducted

France,  Germany,  Hungary,  Latvia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity (PI)	Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). 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.	1 to 72 hours post-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