Preemptive analgesia with bupivacaine in mastectomy

ISRCTN	ISRCTN33898123
DOI	https://doi.org/10.1186/ISRCTN33898123
Protocol serial number	001
Sponsor	Medical University of Gdansk (Poland)
Funder	Investigator initiated and funded (Poland)

Submission date: 07/02/2010
Registration date: 22/02/2010
Last edited: 01/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jacek Zielinski
Scientific

Debinki 7
Gdansk
80210
Poland

Study information

Primary study design	Interventional
Study design	Prospective double-blind single centre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A randomised double-blind placebo-controlled trial of preemptive analgesia with bupivacaine in patients undergoing mastectomy for carcinoma of the breast
Study objectives	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(s)	Local Ethics Committee Medical University of Gdansk approved on the 6th July 2009 (ref: 195/2009)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Bupivacaine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	12/07/2009
Date of final enrolment	15/03/2010

Locations

Countries of recruitment

Poland

Study participating centre

Debinki 7

Gdansk
80210
Poland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes