Clinical trial NCT03448913: Block REducing Pain After Surgery Trial
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain Post-Procedural
Keywords: Anesthesia, Regional ;PECS block
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients needing breast surgery (mastectomy, partial mastectomy and/or axillary clearence)

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* programmed breast surgery
* informed consent

Exclusion Criteria:

* bilateral breast surgery

Primary outcomes:
measure: Chronic pain at six months
timeFrame: six months
Secondary outcomes:
measure: Chronic pain at three months
timeFrame: three months
measure: Chronic pain at nine months
timeFrame: nine months
measure: Chronic pain at twelve months
timeFrame: twelve months
measure: Difference in opioid consumption during surgery
timeFrame: day of surgery
measure: Difference in pain in the first 24 hours after surgery
timeFrame: first 24 hours after surgery
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
affiliation: University of Padova
name: Alessandro De Cassai, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
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. doi: 10.1038/sj.bjc.6602304.
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. No abstract available.
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 9.