Pectoral Nerve Block II and Erector Spine Plane Block in Breast Cancer Surgery

Chronic Pain Clinical Trial

Official title:

Research of the Effects of Pectoralis Nerve Block II and Erector Spina Plan Block in Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04135157
• Other study ID #: PA191001001
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2021
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Analgesia
• Anesthesia
• Chronic Pain
• Erector Spine Plane Block
• Patient Controlled Analgesia
• Pectoralis Nerve Block

Intervention

Procedure:
• Pectoralis nerve block II
PECS II block will be performed 30 min. before general anesthesia.
• Erector spine plane block
ESP block will be performed 30 minutes before general anesthesia.

Other:
• Control
Only general anesthesia will be performed.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University Faculty of Medicine	Samsun

Sponsors (2)

Lead Sponsor	Collaborator
Ondokuz Mayis University	CENGIZ KAYA (ckaya)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The time of first analgesic demand from the PCA device.	The time of first analgesic demand was defined as the time to first PCA bolus after patient PACU arrival.	1 day
Primary	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.	1 day
Secondary	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)	1 day
Secondary	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.	During the surgery
Secondary	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)	1 day
Secondary	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	1 day
Secondary	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)	3. month after surgery