Continuous Pectoral Nerve Block in Breast Cancer Surgery

• Sponsor: Antalya Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04036370
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 13.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nerve Blocks; Breast Surgery; Postoperative Pain	Procedure: PECS group; Other: Control group	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomised ControlledRandomised Controlled
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery
• Actual Study Start Date: Jul 30, 2019
• Actual Primary Completion Date: Nov 15, 2019
• Actual Study Completion Date: Nov 15, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. analgesia consumption [12 hours]

   postoperative 12 hours

Secondary Outcome Measures

1. analgesia consumption [during the surgery]

   intraoperative

2. postoperative Numeric Rating Scale (NRS) score [0, 1, 3, 6, 9, 12 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation	Antalya		Turkey	07100

Sponsors and Collaborators

• Antalya Training and Research Hospital

Investigators

• Principal Investigator: Arzu Karaveli, Antalya TRH

Study Documents (Full-Text)

None provided.

More Information

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.

• Responsible Party: Arzu Karaveli, University of Health Sciences Antalya Training and Research Hospital, Antalya Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT04036370
• Other Study ID Numbers: 13/21
• First Posted: Jul 29, 2019
• Last Update Posted: Nov 18, 2019
• Last Verified: Jul 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Arzu Karaveli, University of Health Sciences Antalya Training and Research Hospital, Antalya Training and Research Hospital: pectoral nerve block (pecs block); breast cancer; postoperative pain; numeric rating scale score (NRS score)
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Nov 18, 2019