Preemptive analgesia with bupivacaine in mastectomy
| ISRCTN | ISRCTN33898123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33898123 |
| Secondary identifying numbers | 001 |
- 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
Scientific
Debinki 7
Gdansk
80210
Poland
Study information
| Study design | Prospective double-blind single centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not yet available in web format, please contact jaziel@gumed.edu.pl to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bupivacaine |
| Primary outcome measure | 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 study start date | 12/07/2009 |
| Completion date | 15/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 (50 within each treatment group) |
| 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
80210
Poland
Sponsor information
Medical University of Gdansk (Poland)
University/education
University/education
Department of Surgical Oncology
Debinki 7
Gdansk
80-210
Poland
| Website | http://www.mug.edu.pl/ |
|---|---|
"ROR" |
https://ror.org/019sbgd69 |
Funders
Funder type
Other
Investigator initiated and funded (Poland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
