Block REducing Pain After Surgery Trial (BREAST)

Prospective Observational Single-centre Study: Difference in the Incidence of Chronic Pain After Breast Surgery Between General Anesthesia and General Anesthesia Associated With PECS Block (Block REducing Pain After Surgery Trial)

This observational study evaluates difference in chronic pain after six months from surgery between patients who received PECS block and general anesthesia versus general anesthesia alone.

Study Overview

• Status: Completed
• Conditions: Chronic Pain Post-Procedural
• Intervention / Treatment: Procedure: PECS block

Detailed Description

PECS block is used as a pain relief technique during breast surgery. However at the actual state of knowledge there is no strong evidence that its use could lower incidence of chronic pain compared to general anesthesia alone.

Moreover for its use an adequate skill with ultrasound machine is required. For this reason only some anesthesiologists in our reality use this technique it in clinical practice.

• Study Type: Observational
• Enrollment (Actual): 140

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35127
    • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients needing breast surgery (mastectomy, partial mastectomy and/or axillary clearence)

Description

Inclusion Criteria:

• programmed breast surgery
• informed consent

Exclusion Criteria:

• bilateral breast surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PECS block+ General anesthesia; Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received PECS block AND general anesthesia for the surgery.	Procedure: PECS block; It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.
General anesthesia; Patients undergoing mastectomy, partial mastectomy and/or axillary clearance who received general anesthesia only for the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain at six months	Presence of chronic pain at six months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain	six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain at three months	Presence of chronic pain at three months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain	three months
Chronic pain at nine months	Presence of chronic pain at nine months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain	nine months
Chronic pain at twelve months	Presence of chronic pain at twelve months after surgery. For this purpose patient will be asked to report presence of pain on breast, neck, axilla or arm. If patient will report pain a further question about intensity (NRS) and quality (we will ask to patient to describe with words from one to three the pain). Furthermore we will ask to patient if he had take any action (eg drugs) to treat pain	twelve months
Difference in opioid consumption during surgery	Difference in opioid consumption during surgery (Fentanyl as mcg/kg/h; Remifentanil as mcg/kg/min)	day of surgery
Difference in pain in the first 24 hours after surgery	maximum and mean NRS score in the first 24 hours after surgery	first 24 hours after surgery

Collaborators and Investigators

• Sponsor: University of Padova
• Investigators: Principal Investigator: Alessandro De Cassai, MD, University of Padova

Publications and helpful links

General Publications

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
• Andersen KG, Kehlet H. Persistent pain after breast cancer treatment: a critical review of risk factors and strategies for prevention. J Pain. 2011 Jul;12(7):725-46. doi: 10.1016/j.jpain.2010.12.005. Epub 2011 Mar 24.
• Macdonald L, Bruce J, Scott NW, Smith WC, Chambers WA. Long-term follow-up of breast cancer survivors with post-mastectomy pain syndrome. Br J Cancer. 2005 Jan 31;92(2):225-30. doi: 10.1038/sj.bjc.6602304.
• Cronin-Fenton DP, Norgaard M, Jacobsen J, Garne JP, Ewertz M, Lash TL, Sorensen HT. Comorbidity and survival of Danish breast cancer patients from 1995 to 2005. Br J Cancer. 2007 May 7;96(9):1462-8. doi: 10.1038/sj.bjc.6603717. Epub 2007 Apr 3.
• Wijayasinghe N, Andersen KG, Kehlet H. Analgesic and Sensory Effects of the Pecs Local Anesthetic Block in Patients with Persistent Pain after Breast Cancer Surgery: A Pilot Study. Pain Pract. 2017 Feb;17(2):185-191. doi: 10.1111/papr.12423. Epub 2016 Feb 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 27, 2018
• First Posted (Actual): February 28, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 10, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Anesthesia, Regional ;PECS block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 4355/AO/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: De.identified individual participant data for all primary and secondary measures will be probably be made available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No