An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SABER-Bupivacaine Treatment 1a
Placebo SABER-Bupivacaine Treatment 1b
Bupivacaine HCl Treatment 1c
SABER-Bupivacaine Treatment 2a
Placebo SABER-Bupivacaine Treatment 2b
Bupivacaine HCl Treatment 2c
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Local anaesthesia, Postoperative pain after open abdominal hysterectomy surgery
Eligibility Criteria
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)
Sites / Locations
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
- Nycomed
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Active Comparator
Experimental
Placebo Comparator
Active Comparator
Arm Label
SABER-Bupivacaine Treatment 1a
Placebo SABER-Bupivacaine Treatment 1b
Bupivacaine HCl Treatment 1c
SABER-Bupivacaine Treatment 2a
Placebo SABER-Bupivacaine Treatment 2b
Bupivacaine HCl Treatment 2c
Arm Description
double-blind
double-blind
double-blind
double-blind
double-blind
double-blind
Outcomes
Primary Outcome Measures
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.
Supplemental Opioid Use
Cumulative IV morphine-equivalent dose of opioid rescue medication
Secondary Outcome Measures
Time to First Opioid Rescue Medication Usage
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.
Full Information
NCT ID
NCT00993226
First Posted
October 9, 2009
Last Updated
May 7, 2021
Sponsor
Durect
Collaborators
Nycomed
1. Study Identification
Unique Protocol Identification Number
NCT00993226
Brief Title
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Durect
Collaborators
Nycomed
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Postoperative pain, Local anaesthesia, Postoperative pain after open abdominal hysterectomy surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
115 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SABER-Bupivacaine Treatment 1a
Arm Type
Experimental
Arm Description
double-blind
Arm Title
Placebo SABER-Bupivacaine Treatment 1b
Arm Type
Placebo Comparator
Arm Description
double-blind
Arm Title
Bupivacaine HCl Treatment 1c
Arm Type
Active Comparator
Arm Description
double-blind
Arm Title
SABER-Bupivacaine Treatment 2a
Arm Type
Experimental
Arm Description
double-blind
Arm Title
Placebo SABER-Bupivacaine Treatment 2b
Arm Type
Placebo Comparator
Arm Description
double-blind
Arm Title
Bupivacaine HCl Treatment 2c
Arm Type
Active Comparator
Arm Description
double-blind
Intervention Type
Drug
Intervention Name(s)
SABER-Bupivacaine Treatment 1a
Intervention Description
5.0 ml
Intervention Type
Drug
Intervention Name(s)
Placebo SABER-Bupivacaine Treatment 1b
Other Intervention Name(s)
POSIMIR® bupivacaine solution
Intervention Description
5.0 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl Treatment 1c
Intervention Description
40 ml
Intervention Type
Drug
Intervention Name(s)
SABER-Bupivacaine Treatment 2a
Intervention Description
7.5 ml
Intervention Type
Drug
Intervention Name(s)
Placebo SABER-Bupivacaine Treatment 2b
Intervention Description
7.5 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl Treatment 2c
Intervention Description
40 ml
Primary Outcome Measure Information:
Title
Pain Intensity (PI)
Description
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.
Time Frame
1 to 72 hours post-surgery
Title
Supplemental Opioid Use
Description
Cumulative IV morphine-equivalent dose of opioid rescue medication
Time Frame
0-3 days after surgery
Secondary Outcome Measure Information:
Title
Time to First Opioid Rescue Medication Usage
Time Frame
0-14 days after surgery
Title
Opioid Related Side Effects
Description
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 Frame
0-7 days after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nycomed Clinical Trial Operations
Organizational Affiliation
Headquarters
Official's Role
Study Chair
Facility Information:
Facility Name
Nycomed
City
Paris
Country
France
Facility Name
Nycomed
City
Bayreuth
Country
Germany
Facility Name
Nycomed
City
Dresden
Country
Germany
Facility Name
Nycomed
City
Budapest
Country
Hungary
Facility Name
Nycomed
City
Békéscsaba
Country
Hungary
Facility Name
Nycomed
City
Debrecen
Country
Hungary
Facility Name
Nycomed
City
Györ
Country
Hungary
Facility Name
Nycomed
City
Nyíregyháza
Country
Hungary
Facility Name
Nycomed
City
Szolnok
Country
Hungary
Facility Name
Nycomed
City
Székesfehérvár
Country
Hungary
Facility Name
Nycomed
City
Tatabánya
Country
Hungary
Facility Name
Nycomed
City
Riga
Country
Latvia
Facility Name
Nycomed
City
Stockholm
Country
Sweden
Facility Name
Nycomed
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy
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