Regional Anesthesia and Partial Mastectomy
Primary Purpose
Breast Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
PECS II
Local anesthetic infiltration
Subcutaneus local anesthetic infiltration
Ropivacaine
bk medical Flex Focus 500 Ultrasound Machine
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasm focused on measuring Segmental Mastectomy,, Analgesia, Regional anesthesia, Breast surgery
Eligibility Criteria
Inclusion Criteria:
- Women scheduled for partial mastectomy (lumpectomy).
Exclusion Criteria:
- Scheduled cryosection
- Axillary node dissection
- Re-resection
- Age under 18 or unable to give an informed concent
- Chronic pain history
- Allergy to local anesthetics
- History of active drug addiction
- Pregnancy
Sites / Locations
- Central Hospital in Karlstad
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PECS+subcutaneus local anesthetic infiltration
Local anesthetic infiltration
Arm Description
Preoperative ultrasound-led PECS II blockade with ropivacaine 3,75mg/ml (2mg/kg). After surgery - wound infiltration by the surgeon with ropivacaine 2mg/ml (1mg/kg).
Prior to scrubbing surgeon infiltrates the thought incision area with ropivacaine 3,75/ml (1mg/kg). Perioperatively after removal of the tumor follows the deep infiltration of the wound with ropivacaine 3,75mg/ml (2mg/kg).
Outcomes
Primary Outcome Measures
maximal pain in PACU measured with 11 point numerical rating scale (NRS)
NRS scale is a validated for assessment of pain. It is a 11 point scale (0-10) used to estimate severity of postoperative pain. On NRS scale the higher value indicates more severe symptoms.
Intraoperative fentanyl use
dose of fentanyl used during surgery in milligrams [mg].
Secondary Outcome Measures
Postoperative analgesic use
Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU.
Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS)
PONV NRS similar to pain NRS is an 11 point scale (0-10) used to estimate severity of postoperative nausea. On NRS scale the higher value indicates more severe symptoms.
Length of stay in PACU
Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.
Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS)
PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.
Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)
NRS scale is a validated for assessment of pain.
Full Information
NCT ID
NCT04824599
First Posted
March 24, 2021
Last Updated
September 3, 2023
Sponsor
Karlstad Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04824599
Brief Title
Regional Anesthesia and Partial Mastectomy
Official Title
Interpectoral and Pectoserratus Plane Block vs Local Anesthetic Infiltration for Partial Mastectomy - a Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karlstad Central Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pectoralis nerves plane block (PECS) first described by Blanco in 2011 has become part of postoperative pain management in breast surgery, thoracic surgery and thoracic trauma. The combination of low complication risk and easiness in mastering of PECS block has made it an interesting alternative to thoracic epidural anesthesia (TEDA) and paravertebral blockade (PVB) for pain treatment after breast surgery. Several studies showed good results when PECS was compared to PVB. PECS blockade however is a procedure requiring some resources in the operating room. An alternative approach is to inject local anesthetics (LA) in the operation field by the surgeon.
The hypothesis' tested in this study is primarily: that PECS blockade is superior to LA being injected by surgeon in the operating field measured by end points such as: post-operative pain, post-operative analgesics use, post-operative nausea or vomiting (PONV) and length of stay in the post anesthesia care unit (PACU).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
Segmental Mastectomy,, Analgesia, Regional anesthesia, Breast surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PECS+subcutaneus local anesthetic infiltration
Arm Type
Active Comparator
Arm Description
Preoperative ultrasound-led PECS II blockade with ropivacaine 3,75mg/ml (2mg/kg). After surgery - wound infiltration by the surgeon with ropivacaine 2mg/ml (1mg/kg).
Arm Title
Local anesthetic infiltration
Arm Type
Active Comparator
Arm Description
Prior to scrubbing surgeon infiltrates the thought incision area with ropivacaine 3,75/ml (1mg/kg). Perioperatively after removal of the tumor follows the deep infiltration of the wound with ropivacaine 3,75mg/ml (2mg/kg).
Intervention Type
Procedure
Intervention Name(s)
PECS II
Other Intervention Name(s)
Pectoral nerves block
Intervention Description
Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.
Intervention Type
Procedure
Intervention Name(s)
Local anesthetic infiltration
Intervention Description
Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
Intervention Type
Procedure
Intervention Name(s)
Subcutaneus local anesthetic infiltration
Intervention Description
Ropivacaine is administered by the surgeon at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Local anesthetic
Intervention Description
Local anesthetic ropivacaine is administered in both study arms according to the study protocol
Intervention Type
Device
Intervention Name(s)
bk medical Flex Focus 500 Ultrasound Machine
Other Intervention Name(s)
High Frequency Linear 8870 probe
Intervention Description
Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.
Primary Outcome Measure Information:
Title
maximal pain in PACU measured with 11 point numerical rating scale (NRS)
Description
NRS scale is a validated for assessment of pain. It is a 11 point scale (0-10) used to estimate severity of postoperative pain. On NRS scale the higher value indicates more severe symptoms.
Time Frame
measured at discharge from PACU (on average 4 hours).
Title
Intraoperative fentanyl use
Description
dose of fentanyl used during surgery in milligrams [mg].
Time Frame
Time is measured from start of the anesthesia until discharge to PACU (on average 3 hours)
Secondary Outcome Measure Information:
Title
Postoperative analgesic use
Description
Postoperative analgesic use is related to pain severity and can be a factor leading to increased length of stay in PACU.
Time Frame
measured at 24 hours postoperatively.
Title
Maximal postoperative nausea and vomiting(PONV) in PACU measured with 11 point numerical rating scale (NRS)
Description
PONV NRS similar to pain NRS is an 11 point scale (0-10) used to estimate severity of postoperative nausea. On NRS scale the higher value indicates more severe symptoms.
Time Frame
measured at discharge from PACU (on average 4 hours).
Title
Length of stay in PACU
Description
Is an dependant of multiple factors and an important measurement that can indicate beneficial therapeutic choice.
Time Frame
on average 4 hours.
Title
Maximal postoperative nausea and vomiting(PONV) after discharge from PACU measured with 11 point numerical rating scale (NRS)
Description
PONV NRS similar to pain NRS is an 11 point scale used to estimate severity of postoperative nausea.
Time Frame
24 hours
Title
Maximal pain after discharge from PACU measured with 11 point numerical rating scale (NRS)
Description
NRS scale is a validated for assessment of pain.
Time Frame
24 hours
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women scheduled for partial mastectomy (lumpectomy).
Exclusion Criteria:
Scheduled cryosection
Axillary node dissection
Re-resection
Age under 18 or unable to give an informed concent
Chronic pain history
Allergy to local anesthetics
History of active drug addiction
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragnar Henningsson, PhD
Organizational Affiliation
Örebro University, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital in Karlstad
City
Karlstad
State/Province
Värmland
ZIP/Postal Code
652 30
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31984479
Citation
Jacobs A, Lemoine A, Joshi GP, Van de Velde M, Bonnet F; PROSPECT Working Group collaborators#. PROSPECT guideline for oncological breast surgery: a systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2020 May;75(5):664-673. doi: 10.1111/anae.14964. Epub 2020 Jan 26.
Results Reference
background
PubMed Identifier
21831090
Citation
Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
Results Reference
background
PubMed Identifier
12190791
Citation
Apfel CC, Roewer N, Korttila K. How to study postoperative nausea and vomiting. Acta Anaesthesiol Scand. 2002 Sep;46(8):921-8. doi: 10.1034/j.1399-6576.2002.460801.x.
Results Reference
background
PubMed Identifier
28820803
Citation
Woodworth GE, Ivie RMJ, Nelson SM, Walker CM, Maniker RB. Perioperative Breast Analgesia: A Qualitative Review of Anatomy and Regional Techniques. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):609-631. doi: 10.1097/AAP.0000000000000641.
Results Reference
background
PubMed Identifier
30700614
Citation
Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
Results Reference
background
PubMed Identifier
21856077
Citation
Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
Results Reference
background
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Regional Anesthesia and Partial Mastectomy
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