Continuous Pectoral Nerve Block in Breast Cancer Surgery

The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery

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

Study Overview

• Status: Completed
• Conditions: Breast Surgery; Postoperative Pain; Nerve Blocks
• Intervention / Treatment: Procedure: PECS group; Other: Control group

Detailed Description

Pectoral nerve block has been developed as an alternative to thoracic paravertebral and/or thoracic epidural blocks in recent years. It is frequently applied for postoperative analgesia in breast cancer surgery.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• American Society of Anesthesiology (ASA) I-II
• 18-65 years
• Body mass index (BMI) ≤40 kg/m2
• Elective breast cancer surgery

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PECS group; 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; Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.
Sham Comparator: Control group; Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block).	Other: Control group; Standard pain follow up and monitorization will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia consumption	postoperative 12 hours	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia consumption	intraoperative	during the surgery
postoperative Numeric Rating Scale (NRS) score	postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12 hours	0, 1, 3, 6, 9, 12 hours

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): November 15, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: July 25, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: November 15, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: breast cancer; postoperative pain; pectoral nerve block (pecs block); numeric rating scale score (NRS score)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 13/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No