Block REducing Pain After Surgery Trial

Chronic Pain Post-Procedural Clinical Trial

— BREAST  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03448913
• Other study ID #: 4355/AO/17
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: March 2019
• Source: University of Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Gender: All
• Age group: 18 Years to 86 Years

Eligibility

Inclusion Criteria:

• programmed breast surgery

• informed consent

Exclusion Criteria:

• bilateral breast surgery

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Post-Procedural

Intervention

Procedure:
• PECS block
It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.

Locations

Country	Name	City	State
Italy	University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. Review. — View Citation

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. — View Citation

Cronin-Fenton DP, Nørgaard M, Jacobsen J, Garne JP, Ewertz M, Lash TL, Sørensen HT. Comorbidity and survival of Danish breast cancer patients from 1995 to 2005. Br J Cancer. 2007 May 7;96(9):1462-8. Epub 2007 Apr 3. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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