Continuous Pectoral Nerve Block in Breast Cancer Surgery
Primary Purpose
Nerve Blocks, Breast Surgery, Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
PECS group
Control group
Sponsored by
About this trial
This is an interventional other trial for Nerve Blocks focused on measuring pectoral nerve block (pecs block), breast cancer, postoperative pain, numeric rating scale score (NRS score)
Eligibility Criteria
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
Sites / Locations
- Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PECS group
Control group
Arm Description
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.
Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block).
Outcomes
Primary Outcome Measures
analgesia consumption
postoperative 12 hours
Secondary Outcome Measures
analgesia consumption
intraoperative
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
Full Information
NCT ID
NCT04036370
First Posted
July 25, 2019
Last Updated
November 15, 2019
Sponsor
Antalya Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04036370
Brief Title
Continuous Pectoral Nerve Block in Breast Cancer Surgery
Official Title
The Effect of Continuous Pectoral Nerve Block on Postoperative Analgesia Consumption in Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 30, 2019 (Actual)
Primary Completion Date
November 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nerve Blocks, Breast Surgery, Postoperative Pain
Keywords
pectoral nerve block (pecs block), breast cancer, postoperative pain, numeric rating scale score (NRS score)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PECS group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Peroperative and postoperative routine analgesic protocol will be performed with no additional intervention (block).
Intervention Type
Procedure
Intervention Name(s)
PECS group
Intervention Description
Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Standard pain follow up and monitorization will be performed.
Primary Outcome Measure Information:
Title
analgesia consumption
Description
postoperative 12 hours
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
analgesia consumption
Description
intraoperative
Time Frame
during the surgery
Title
postoperative Numeric Rating Scale (NRS) score
Description
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
Time Frame
0, 1, 3, 6, 9, 12 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Karaveli
Organizational Affiliation
Antalya TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
City
Antalya
ZIP/Postal Code
07100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22939099
Citation
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.
Results Reference
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PubMed Identifier
23453236
Citation
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.
Results Reference
background
PubMed Identifier
25376971
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.
Results Reference
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Continuous Pectoral Nerve Block in Breast Cancer Surgery
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