Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
Primary Purpose
Anesthesia, Analgesia, Acute Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pectoralis nerve block II
Erector spine plane block
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Anesthesia focused on measuring Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block
Eligibility Criteria
Inclusion Criteria:
- ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
Exclusion Criteria:
- Age <18 or> 65, ASA 3-4 patients
- Obesity (> 100 kg, BMI> 35 kg / m2)
- Patients undergoing bilateral mastectomy
- Pregnancy
- Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
- Serious renal, cardiac, hepatic disease
- Hypersensitivity to local anesthetics or a history of allergy
- Patients with a history of opioid use longer than four weeks
- Patients with psychiatric disorders or communication difficulties
- Patients with chest deformity
- Patients with previous breast surgery except diagnostic biopsies
- Patients who do not want to participate
Sites / Locations
- Ondokuz Mayıs University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
PECS II or ESP
Control
Arm Description
PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.
In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.
Outcomes
Primary Outcome Measures
Opioid consumption in the first 24 hours after surgery
Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.
Secondary Outcome Measures
Post-operative acute pain
Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Remifentanil consumption during the surgery
Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded.
The incidences of post-operative nausea and vomiting (PONV)
The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one)
The number of patient required rescue analgesia
The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery
Post-operative chronic pain
Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Full Information
NCT ID
NCT04135157
First Posted
October 19, 2019
Last Updated
August 12, 2021
Sponsor
Ondokuz Mayıs University
Collaborators
CENGİZ KAYA (ckaya)
1. Study Identification
Unique Protocol Identification Number
NCT04135157
Brief Title
Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
Official Title
Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
Collaborators
CENGİZ KAYA (ckaya)
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
This study evaluates the analgesic effects of pectoralis nerve block (PECS II) and erector spinae plane block (ESP) in patients having segmental mastectomy and sentinel lymph node biopsy (SLNB). Each one-third of patients will have ESP block and pectoralis nerve block (PECS II) 30 min before general anesthesia , while other one-third of patients will have only general anesthesia.
Detailed Description
It has been proven that PECS II and ESP both supply effective analgesia in the first 24 hours after mastectomy. But they do so by different mechanishms.
This study is to survey that ESP and PECS II may supply acute and chronic analgesia by reducing pain scores in the first 24 hours and 3 months after the surgery, also the comparison of the analgesic activity among themselves for acute / chronic pain and opioid consumption will be searched.
In this study patients are divided into three groups. Patients in PECS group will have PECS II block in a separate section from the operating rooms (PNB practice room). In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
Patients in ESP group will have ESP block in a separate section from the operating rooms (PNB practice room). In addition, PCA will be used in the first 24 hours postoperatively.
Patients in control group will not be performed nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, PCA will be used in the first 24 hours postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Analgesia, Acute Pain, Chronic Pain, Pectoralis Nerve Block, Erector Spine Plane Block, Patient Controlled Analgesia
Keywords
Regional Anesthesia, Acute and chronical pain, Pectoralis nerve block, Erector spine plane block
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer generated generated random numbers.
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The anesthesia doctor who will perform the peripheral nerve block will be informed with a sealed envelope by an independent assistant outside the study.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PECS II or ESP
Arm Type
Experimental
Arm Description
PECS II or ESP block are performed 30 minutes before general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
In the control group, patients will have only general anesthesia. PCA is used for all the patients in the first 24 hours postoperatively.
Intervention Type
Procedure
Intervention Name(s)
Pectoralis nerve block II
Other Intervention Name(s)
PECS II
Intervention Description
PECS II block will be performed 30 min. before general anesthesia.
Intervention Type
Procedure
Intervention Name(s)
Erector spine plane block
Other Intervention Name(s)
ESP
Intervention Description
ESP block will be performed 30 minutes before general anesthesia.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Only general anesthesia will be performed.
Primary Outcome Measure Information:
Title
Opioid consumption in the first 24 hours after surgery
Description
Morphine consumption in the first 24 hours will be counted by IV PCA. Patients will be able to request opioids via PCA device when the vas score is 4 points or more when the arm is in the resting position.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Post-operative acute pain
Description
Pain status will be evaluated based on VAS scores in two different positions: arm at rest and arm in abduction. Pain status will be evaluated at 1-3-6-12-24. hours after surgery. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Time Frame
1 day
Title
Remifentanil consumption during the surgery
Description
Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-60 (bispectral index). When the BIS is between 40-60, remifentanil infusion rate will be changed considering ± 20% changes in blood pressure compared to baseline values.The total amount of remifentanil consumed will be recorded.
Time Frame
During the surgery
Title
The incidences of post-operative nausea and vomiting (PONV)
Description
The patients will be evaluated according to the five-stage verbal descriptive PONV scale. If it is 3 points or more, ondansetron 4 mg IV will be administered. Wait for 8 hours for the next dose of ondansetron. (0 = None, 1 = Slight nausea, 2 = Moderate nausea, 3 = Once vomiting, 4 = vomiting more than one)
Time Frame
1 day
Title
The number of patient required rescue analgesia
Description
The number of patient requires rescue analgesic will be recorded at 1-3-6-12-24. hours after surgery
Time Frame
1 day
Title
Post-operative chronic pain
Description
Pain status will be evaluated in the third month after surgery based on VAS scores in two different positions: arm at rest and arm in abduction. Each VAS is scores 0-10. (0=no pain ; 10=pain as bad as can be)
Time Frame
3. month after surgery
Other Pre-specified Outcome Measures:
Title
The time of first analgesic demand from the PCA device.
Description
The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival.
Time Frame
1 day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women with breast cancer having segmental mastectomy and sentinel lymph node biopsy (SLNB)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-2 patients between the age of 18-65, scheduled for elective unilateral segmental mastectomy + sentinel lymph node biopsy
Exclusion Criteria:
Age <18 or> 65, ASA 3-4 patients
Obesity (> 100 kg, BMI> 35 kg / m2)
Patients undergoing bilateral mastectomy
Pregnancy
Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
Serious renal, cardiac, hepatic disease
Hypersensitivity to local anesthetics or a history of allergy
Patients with a history of opioid use longer than four weeks
Patients with psychiatric disorders or communication difficulties
Patients with chest deformity
Patients with previous breast surgery except diagnostic biopsies
Patients who do not want to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CENGİZ KAYA, MD
Organizational Affiliation
Ondokuz Mayıs University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ondokuz Mayıs University Faculty of Medicine
City
Samsun
ZIP/Postal Code
55270
Country
Turkey
12. IPD Sharing Statement
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Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery
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