Role of Wound Installation With Bupivacaine Through Surgical Drains in Postoperative Analgesia in Modified Radical Mastectomy
Overview
- Phase
- Phase 4
- Intervention
- 40ml of 0.25% bupivacaine
- Conditions
- Pain, Postoperative
- Sponsor
- Alexandria University
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Visual analogue pain score
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
in this study we are investigating the role of instillation of Bupivacaine through surgical drains at the end of mastectomy surgeries in controlling post operative pain and decreasing their pain killers requirement in the early postoperative period
Detailed Description
patients were enrolled into 2 groups. in one group the wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. in the other group the wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group) patients and health care providers were blinded as regard the study group patients enrolled in. Visual Analog Pain Scale which is a score for detection of how much the patient is annoyed from the pain- was assessed two and four hours post-operative then every four hours thereafter.
Investigators
Mahmoud A. Alhussini
lecturer surgical oncology
Alexandria University
Eligibility Criteria
Inclusion Criteria
- •female patients with unilateral breast cancer candidates for total mastectomy and axillary dissection
Exclusion Criteria
- •Male patients
- •Bilateral breast cancer.
- •Patients with a history of a long duration of NSAID intake or other painkillers, drug abuse
- •Patients with chest wall pain like Tietze syndrome, history of angina pectoris or recent HZV infection.
- •Patients with known psychological or mental problems.
- •Patients who were not exposed to axillary dissection
Arms & Interventions
Bupivacaine
The wound was installed by 40ml of 0.25% bupivacaine through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes.
Intervention: 40ml of 0.25% bupivacaine
Placebo
The wound was installed by 40ml of 0.9% normal saline through axillary and chest wall drains (20ml in each drain). Then, the drains were clamped for 20 minutes. (placebo group)
Intervention: 40ml of 0.9% normal saline
Outcomes
Primary Outcomes
Visual analogue pain score
Time Frame: first 24 hours
The intensity of pain will be assessed by the VAS score
Number of demands for analgesic
Time Frame: First 24 hours
How many times the patient will require analgesics
Timing of first demand for analgesic
Time Frame: First 24 hours
Time lapse between recovery from surgery and first demand for analgesic