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

Durect115 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

115

Conditions

Postoperative Pain

Interventions

SABER-Bupivacaine Treatment 1aDRUG

5.0 ml

Placebo SABER-Bupivacaine Treatment 1bDRUG

5.0 ml

Bupivacaine HCl Treatment 1cDRUG

40 ml

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (14)

Nycomed

Paris, France

Nycomed

Bayreuth, Germany

Nycomed

Dresden, Germany

Nycomed

Békéscsaba, Hungary

Outcomes

Primary Outcomes

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.

Time frame: 1 to 72 hours post-surgery

Supplemental Opioid Use

Cumulative IV morphine-equivalent dose of opioid rescue medication

Time frame: 0-3 days after surgery

Secondary Outcomes

Time to First Opioid Rescue Medication Usage

Time frame: 0-14 days after surgery

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.

Time frame: 0-7 days after surgery

Data from ClinicalTrials.gov

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