Postoperative pain control after breast surgery

• Register: ISRCTN
• Last refreshed on: 11 February 2019
• Main ID: ISRCTN76105318
• Date of registration: 30/06/2016
• Prospective Registration: No
• Primary sponsor: National Cancer Institute, Cairo University
• Public title: Postoperative pain control after breast surgery
• Scientific title: Transdermal fentanyl patch as an adjuvant to paravertebral block for pain control after breast cancer surgery : a randomized double blind controlled trial
• Date of first enrolment: 22/03/2016
• Target sample size: 50
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN76105318
• Study type: Observational
• Study design: Observational study 3 months duration arandomized double blind controlled trial (Quality of life)

Countries of recruitment

Egypt

Contacts

• Name: Ahmed Bakir

Key inclusion & exclusion criteria

Inclusion criteria: Female with cancer breast with physical status ASA 1-3 scheduled for cancer breast surgery
Exclusion criteria:
Patients with:
1. Central neuropathy
2. Coagulopathy
3. Psychiatric illness
4. History of drug abuse
5. Liver or renal impairment


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Postoperative pain (breast cancer patients)
Cancer

Intervention(s)

Patients will be randomly classified using sealed envelope into two equal groups each of 25 patients.

1. Group A: (TDF & PVB)
Patients of this group will obtain a transdermal fentanyl (TDF) patch 25 µg/h three hours before induction of anesthesia. Paravertebral block (PVB) will be performed using 20 mL of bupivacaine 0.25% then general anesthesia will be induced.

2. Group B: (PVB)
Paravertebral block will be performed using 20 mL of bupivacaine 0.25% then general anesthesia will be induced.

Heart rate and blood pressure will be measured before surgery and during the procedure itself.
After surgery patients will be transferred to the post-anesthesia care unit (PACU) and will be monitored for vital signs (heart rate, blood pressure, respiratory rate, and SPO2), level of sedation and pain.

Primary Outcome(s)

1. The time of the first request for analgesia post surgery
2. Total analgesic consumption in the first 48 hours after surgery

Secondary Outcome(s)

1. Postoperative adverse effects such as nausea, vomiting, hypotension, bradycardia, and cardiac arrhythmia
2. Postoperative complications of the block including accidental pneumothorax and vascular puncture

Secondary ID(s)

201516015.2

Source(s) of Monetary Support

National Cancer Institute, Cairo University

Ethics review

Status:
Approval date:
Contact:

Cairo University National Cancer Institutional Review Board, 22/03/2016, ref: 201516015.2

Results

• Results available: Yes
• Date Completed: 22/06/2016