NCT04586751

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

October 6, 2020

Last Update Submit

February 5, 2023

Conditions

Pain SyndromePain, PostoperativeChronic PainBreast CancerBreast Soft Tissue NeoplasmBreast NeoplasmsBreast Cancer FemaleBreast PainAnesthesia

Outcome Measures

Primary Outcomes (3)

  • pain score 6 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 6 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    6 hours after surgery

  • pain score 12 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 12 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    12 hours after surgery

  • pain score 24 hours postoperatively

    pain score by the use of Numeric Rating Scale (NRS) 24 hours postoperatively, ranging from 0 to 10, where 0 means "no pain" and 10 means "worst pain imaginable"

    24 hours after surgery

Secondary Outcomes (6)

  • incidence of chronic pain

    3 months after surgery

  • incidence of chronic pain

    6 months after surgery

  • time of first request for analgesia

    24 hours postoperatively

  • analgesic consumption in mg of morphine

    24 hours postoperatively

  • satisfaction from postoperative analgesia

    24 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

study group

ACTIVE COMPARATOR

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed. In specific, using the in-plane insertion technique, after visualization of the entire needle as a bright hyperechoic line and aiming between pectoralis major and pectoralis minor at the 3rd rib level, 2 ml of normal saline 09% will be injected first, to verify the correct position of the needle. Followingly, 10 mL ropivacaine 0.5% will be injected in order to block the lateral and medial pectoral nerves. Finally, another 15 ml of ropivacaine 0.5% plus 4 mg of dexamethasone will be injected between the pectoralis minor muscle and the anterior serratus muscle,at the level of the 4th and 5th ribs, after negative aspiration, to block the intercostal and intercostobrachial nerves. Using the color Doppler the vessels will be identified, so that their puncture is avoided during the procedures.

Other: Pecs block

control group

SHAM COMPARATOR

no regional block will be performed

Other: no Pecs block

Interventions

Pecs blockOTHER

Pecs block under real-time ultrasound guidance after anesthesia induction will be performed.

study group
no Pecs blockOTHER

no regional block will be performed in this arm

control group

Eligibility Criteria

Age20 Years - 85 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

General Hospital of Limassol

Limassol, Cyprus

Location

General Hospital of Nicosia

Nicosia, Cyprus

Location

Aretaieion University Hospital

Athens, 115 28, Greece

Location

Related Publications (7)

  • 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.

    PMID: 25376971BACKGROUND

  • 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.

    PMID: 30386013BACKGROUND

  • 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.

    PMID: 24796220BACKGROUND

  • 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.

    PMID: 20562750BACKGROUND

  • 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.

    PMID: 28949315BACKGROUND

  • 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.

    PMID: 20832052BACKGROUND

  • 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.

    PMID: 31564259BACKGROUND

Related Links

MeSH Terms

Conditions

Somatoform DisordersPain, PostoperativeChronic PainBreast NeoplasmsMastodynia

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Kassiani Theodoraki

    Aretaieion University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

August 1, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)CY(2)