ISRCTN - ISRCTN76105318: Postoperative pain control after breast surgery

Plain English Summary

Background and study aims
Breast cancer is the most common cancer in women that requires frequent surgery. Nearly 40% breast surgery patients experience significant amount of pain just after surgery, reflecting the inadequacy of conventional pain management.Most of the responses of the human body to post-surgical pain (pain after surgery) have been proven to be detrimental to the patient’s homeostasis (normal body function) and recovery. Furthermore, up to 50% of breast cancer patients suffer from chronic (long lasting) pain after surgery, and inadequate pain relief (analgesia) is considered to be a reason for this. A number of therapeutic measures have been accepted as a part of a “multi-modal” approach to postoperative pain control. Thoracic paravertebral block (PVB) is used for pain relief after chest (thoracotomy) surgery and mastectomy (removal of the breast). PVB can provide profound, long-lasting deafferentation (blocking or destroying nerve cells that cause pain). Unlike general anesthesia, PVB can provide postoperative analgesia which much more effective than other forms of pain relief. It can also lead to less nausea and vomiting, a shorter recovery time, and earlier discharge from hospital. The use of PVB in patients undergoing ambulatory (outpatient) breast surgery has a cost-saving potential. Fentanyl is a synthetic (man-made) opioid with a short-acting pain killing effect that is suitable to be applied directly to the skin. The aim of this study is to study the effect of transdermal fentanyl (that is, fentanyl given though the skin) via a method called the transdermal therapeutic system (TTS). The aim of this study is to investigate the effect of transdermal fentanyl as adjuvant to paravertebral block for pain control in breast cancer surgery.

Who can participate?
Women with breast cancer scheduled for surgery.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 are given a
Patients will be randomly classified using sealed envelope into two equal groups each of 25transdermal fentanyl (TDF) patch three hours before their operation. Paravertebral block (PVB) is also be performed before the patient is given general anesthesia. Those in group 2 are given the PVB only. Heart rate and blood pressure are monitored before and during surgery.After surgery patients are transferred to the post-anesthesia care unit (PACU) and are monitored for vital signs, level of sedation and pain.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
National Cancer Institute, Cairo University

When is the study starting and how long is it expected to run for?
March 2016 to June 2016

Who is funding the study?
National Cancer Institute, Cairo University

Who is the main contact?
Dr Ahmed Bakir
ahmed_bakir77@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ahmed Bakir

ORCID ID

Contact details

National Cancer Institute
Cairo University
Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
+201115661922
ahmed_bakir77@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

201516015.2

Study information

Scientific title

Transdermal fentanyl patch as an adjuvant to paravertebral block for pain control after breast cancer surgery : a randomized double blind controlled trial

Acronym

Study hypothesis

The aim of this work is to study the effect of transdermal fentanyl as adjuvant to paravertebral block for pain control in breast cancer surgery.

Ethics approval

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

Study design

Observational study 3 months duration arandomized double blind controlled trial

Primary study design

Observational

Secondary study design

Nested case-control study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Postoperative pain (breast cancer patients)

Intervention

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.

Intervention type

Phase

Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date

22/03/2016

Overall trial end date

22/06/2016

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Female with cancer breast with physical status ASA 1-3 scheduled for cancer breast surgery

Participant type

Mixed

Age group

Mixed

Gender

Female

Target number of participants

50 participants

Participant exclusion criteria

Patients with:
1. Central neuropathy
2. Coagulopathy
3. Psychiatric illness
4. History of drug abuse
5. Liver or renal impairment

Recruitment start date

22/03/2016

Recruitment end date

22/06/2016

Locations

Countries of recruitment

Egypt

Trial participating centre

National Cancer Institute, Cairo University
Kasr Al Eini Street Fom El Khalig
Cairo
11796
Egypt

Sponsor information

Organisation

National Cancer Institute, Cairo University

Sponsor details

Kasr Al Eini Street
Fom El Khalig
Cairo
11796
Egypt
+201115661922
ahmed_bakir77@yahoo.com