Continuous Pectoral Nerve Block in Breast Cancer Surgery

NCT04036370 | Completed

• 1 other identifier: 13/21
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the effect of continuous pectoral nerve block on postoperative analgesia consumption in breast cancer surgery.

Conditions

Nerve Blocks; Breast Surgery; Postoperative Pain

Keywords

pectoral nerve block (pecs block); breast cancer; postoperative pain; numeric rating scale score (NRS score)

Outcome Measures

Primary Outcomes (1)

• analgesia consumption

  postoperative 12 hours

  12 hours

Secondary Outcomes (2)

• analgesia consumption

  during the surgery

• postoperative Numeric Rating Scale (NRS) score

  0, 1, 3, 6, 9, 12 hours

Study Arms (2)

PECS group

ACTIVE COMPARATOR

In addition to routine analgesic protocol; before anaesthesia induction; following the PECS I + II block, a continuous infusion catheter will be placed at the PECS II block level under the guidance of USG, and local anesthetic infusion will be started via the catheter at the end of the operation.

Procedure: PECS group

Control group

SHAM COMPARATOR

Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block).

Other: Control group

Interventions

PECS group PROCEDURE

Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.

PECS group

Control group OTHER

Standard pain follow up and monitorization will be performed.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiology (ASA) I-II
• years
• Body mass index (BMI) ≤40 kg/m2
• Elective breast cancer surgery

You may not qualify if:

• ASA ≥4
• under 18 years of age or over 65 years of age
• declining to give written informed consent
• history of allergy to the local anesthetics
• contraendications of peripheral block or local anesthetic infiltration (local infection, coagulopathy, etc)
• history of breast surgery
• treatment due to psychiatric disorder
• history of treatment for chronic pain
• history of nerve blocks in order to treat postoperative pain

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

Location

Related Publications (3)

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 BACKGROUND

• Blanco R, Parras Maldonado T. Reply to the article entitled "Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery". Reply of the authors. Rev Esp Anestesiol Reanim. 2013 May;60(5):296-7. doi: 10.1016/j.redar.2013.01.002. Epub 2013 Feb 27. No abstract available.

  PMID: 23453236 BACKGROUND

• 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: 25376971 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Arzu Karaveli

  Antalya TRH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Health Sciences Antalya Training and Research Hospital

Model Details: Randomised Controlled

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: July 30, 2019
• Primary Completion: November 15, 2019
• Study Completion: November 15, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)