Clinical trial NCT04586751: The Impact of Pecs Blocks on Postmastectomy Pain Syndrome
Official title: The Impact of Pecs Blocks on the Appearance of Post Mastectomy Chronic Pain Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Syndrome
Pain, Postoperative
Chronic Pain
Breast Cancer
Breast Soft Tissue Neoplasm
Breast Neoplasms
Breast Cancer Female
Breast Pain
Anesthesia
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms

Detailed description: Breast cancer is the commonest type of malignancy in women. Chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. Chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. Risk factors for developing post-mastectomy pain syndrome include younger age, increased Body mass Index (BMI), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. Consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients.

The aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in Cyprus, discover its associated risk factors and explore the impact of Pecs Blocks on the appearance of post mastectomy chronic pain symptoms.

During the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (NRS) graded from 0 to 10. Standardized anesthesia will be administered. All patients will receive 1000 mg of paracetamol and 0.07 mg/ Kg of morphine intraoperatively. In the Post-Anesthesia Care Unit (PACU), patients will receive additional morphine boluses on request, until NRS score is lesser or equal than 4. Postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. After discharge from PACU, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol.

Numerical rating scores (NRS) at rest and movement will be measured at 6h, 12h and 24h postoperatively. Additionally, the time to first request for analgesia after surgery will be noted.

All patients will also be evaluated 3 and 6 months after surgery with the use of NRS at rest and movement and additionally, via the use of Douleur Neuropathique (DN4) questionnaire for the occurence of neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I-III patients
* Breast cancer patients
* Patients who receive operative treatment

Exclusion Criteria:

* inability to consent to the study due to language barriers or cognitive dysfunction -
* skin infection at the puncture site
* contraindication to paracetamol administration
* known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers

Primary outcomes:
measure: pain score 6 hours postoperatively
timeFrame: 6 hours after surgery
measure: pain score 12 hours postoperatively
timeFrame: 12 hours after surgery
measure: pain score 24 hours postoperatively
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: incidence of chronic pain
timeFrame: 3 months after surgery
measure: incidence of chronic pain
timeFrame: 6 months after surgery
measure: time of first request for analgesia
timeFrame: 24 hours postoperatively
measure: analgesic consumption in mg of morphine
timeFrame: 24 hours postoperatively
measure: satisfaction from postoperative analgesia
timeFrame: 24 hours postoperatively
measure: Pecs block related complications
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: General Hospital of Limassol
city: Nicosia
country: Cyprus
facility: General Hospital of Nicosia
city: Athens
country: Greece
facility: Aretaieion University Hospital
Study officials:
affiliation: Aretaieion University Hospital
name: Kassiani Theodoraki
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.
citation: Thomas M, Philip FA, Mathew AP, Jagathnath Krishna KM. Intraoperative pectoral nerve block (Pec) for breast cancer surgery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):318-323. doi: 10.4103/joacp.JOACP_191_17.
citation: Sykioti P, Zis P, Vadalouca A, Siafaka I, Argyra E, Bouhassira D, Stavropoulou E, Karandreas N. Validation of the Greek Version of the DN4 Diagnostic Questionnaire for Neuropathic Pain. Pain Pract. 2015 Sep;15(7):627-32. doi: 10.1111/papr.12221. Epub 2014 May 5.
citation: Bras M, Dordevic V, Gregurek R, Bulajic M. Neurobiological and clinical relationship between psychiatric disorders and chronic pain. Psychiatr Danub. 2010 Jun;22(2):221-6.
citation: Dujmovic A, Marcinko D, Bulic K, Kisic H, Dudukovic M, Mijatovic D. Quality of Life and Depression Among Female Patients Undergoing Surgical Treatment for Breast Cancer: A Prospective Study. Psychiatr Danub. 2017 Sep;29(3):345-350. doi: 10.24869/psyd.2017.345.
citation: Khan RS, Ahmed K, Blakeway E, Skapinakis P, Nihoyannopoulos L, Macleod K, Sevdalis N, Ashrafian H, Platt M, Darzi A, Athanasiou T. Catastrophizing: a predictive factor for postoperative pain. Am J Surg. 2011 Jan;201(1):122-31. doi: 10.1016/j.amjsurg.2010.02.007. Epub 2010 Sep 15.
citation: Najeeb HN, Mehdi SR, Siddiqui AM, Batool SK. Pectoral Nerves I, II and Serratus Plane Blocks in Multimodal Analgesia for Mastectomy: A Randomised Clinical Trial. J Coll Physicians Surg Pak. 2019 Oct;29(10):910-914. doi: 10.29271/jcpsp.2019.10.910.