Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
A randomised double-blind placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast
Acronym
Study hypothesis
To test a hypothesis that preemptive analgesia with bupivacaine applied in the area of surgical incision in patients undergoing mastectomy for carcinoma of the breast would reduce post-operative acute pain and would reduce the amount of analgesics used during surgery and in post-operative period.
As of 19/03/2010 this record was updated to include the actual end date of this trial; the initial anticipated end date was 31/03/2010.
Ethics approval
Local Ethics Committee Medical University of Gdansk approved on the 6th July 2009 (ref: 195/2009)
Study design
Prospective double-blind single centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not yet available in web format, please contact jaziel@gumed.edu.pl to request a patient information sheet
Condition
Breast cancer
Intervention
Depending on random allocation to the specific group, on the day of surgery one of the preparations (40 ml) was prepared:
Group A: 100 mg bupivacainum hydrochloricum dissolved in 0.9 % NaCl solution
Group B (control): 0.9% NaCl
After intubation the preparation was injected subcutaneously along the intended line of incision. Fifteen minutes later surgical procedure was started.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bupivacaine
Primary outcome measures
The quality of multimodal analgesia provided during surgical treatment is assessed in view of fentanyl consumption. In the post-operative period the insensitivity of pain is measured using Visual Analogue Score (VAS) scale ranged 0 - 10, where 0 = no pain and 10 = worst pain. The patient is assessed straight after waking from anaesthesia and at 1, 2, 3, 4, 8, 12, 16, 20, 24, 36 and 48 hours after surgery. In addition, the time of the first morphine dose delivered by patient controlled anaesthesia (PCA), total morphine consumption and the number of attempts to launch PCA during lockout is measured. For assessment of pain insensitivity each patient receive a slide with the VAS scale.
Secondary outcome measures
1. Analysis of numerical values of pain intensity according to VAS scale summed up in the following time ranges: 0 - 4 hours, 4 - 12 hours, 12 - 24 hours, 24 - 48 hours, 0 - 12 hours and 12 - 48 hours
2. Comparison between the group of patients reporting pain (VAS 1 - 10) versus the group of patients with no pain complain (VAS = 0) and a comparison between the group of patients with no or only slight pain sensation (VAS 0 - 2) versus the group of patients with stronger pain (VAS greater than 2)
3. Amounts of morphine consumed in the following time ranges: 0 - 1 hours (from the moment of the end of the surgery till the end of the first post-operative hour), 0 - 4 hours, 0 - 12 hours, 1 - 2 hours and 4 - 12 hours
Overall trial start date
12/07/2009
Overall trial end date
15/03/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Breast cancer patients in disease stage I, II and IIIA without neoadjuvant treatment
2. Patients qualified for radical modified mastectomy
3. Informed consent obtained from the patient
4. Females aged 35 - 90 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 (50 within each treatment group)
Participant exclusion criteria
1. No informed consent obtained from the patient
2. Allergy to bupivacaine or any other local analgesic agent
3. Allergy to any of the drugs used in the analgesia protocol
4. Prior surgically treatment for breast cancer
5. Patient history with treatment of chronic pain
6. Patients with any psychiatric disorders
7. Patients weight below 50 kg
Recruitment start date
12/07/2009
Recruitment end date
15/03/2010
Locations
Countries of recruitment
Poland
Trial participating centre
Debinki 7
Gdansk
80210
Poland
Sponsor information
Organisation
Medical University of Gdansk (Poland)
Sponsor details
Department of Surgical Oncology
Debinki 7
Gdansk
80-210
Poland
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (Poland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21959614
Publication citations
-
Results
Zielinski J, Jaworski R, Smietanska I, Irga N, Wujtewicz M, Jaskiewicz J, A randomized, double-blind, placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast., Med. Sci. Monit., 2011, 17, 10, CR589-97.