Condition category
Cancer
Date applied
07/02/2010
Date assigned
22/02/2010
Last edited
01/02/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jacek Zielinski

ORCID ID

Contact details

Debinki 7
Gdansk
80210
Poland

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

http://www.mug.edu.pl/

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

  1. 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.

Additional files

Editorial Notes