Pectoral Nerve Block and Erector Spine Plane Block in Breast Cancer Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04135157|
Recruitment Status : Recruiting
First Posted : October 22, 2019
Last Update Posted : April 24, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia Analgesia Acute Pain Chronic Pain Pectoralis Nerve Block Erector Spine Plane Block Patient Controlled Analgesia||Procedure: Pectoralis nerve block Procedure: Erector spine plane block Other: Control||Not Applicable|
It has been proven that pectoralis nerve block (PECs) and erector spine plane block (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 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 and chronic pain will be searched.
In this study patients are divided into three groups. Group A - Patients in group A will have COMBIPECs block (PECs2 -> PECs1) 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.
Group B - Patients in group B will have ESP 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.
Group C - Patients in group C will not be performed planar nerve block. Only general anesthesia (GA) will be performed in the operation room. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 randomization codes.|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The anesthesia doctor who will perform the peripheral nerve block (PNB) will be informed with a sealed envelope by an independent assistant outside the study, and the patient will not know which block is performed.|
|Primary Purpose:||Supportive Care|
|Official Title:||Research of the Effects of Pectoralis Nerve Blocks and Erector Spina Plan Block on Post-operative Acute and Chronic Pain in Breast Cancer Surgery|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
Experimental: PECs & ESP
Pectoralis nerve block and erector spine plane block are performed 30 minutes before general anesthesia. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively.
Procedure: Pectoralis nerve block
Pecs block will be performed 30 min. before general anesthesia.
Other Name: PECs
Procedure: Erector spine plane block
ESP block will be performed 30 minutes before general anesthesia.
Other Name: ESP
Active Comparator: Control
In the control group, patients will have only general anesthesia. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively.
Only general anesthesia will be performed.
- Post-operative acute pain [ Time Frame: 1 day ]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)
- Post-operative chronic pain [ Time Frame: 3. month after surgery ]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)
- Opioid consumption in the first 24 hours after surgery [ Time Frame: 1 day ]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 above 4 when the arm is in the resting position.
- Remifentanil consuption during the surgery [ Time Frame: During the surgery ]Following induction of general anesthesia, anesthesia maintenance will be continued with sevoflurane to BIS 40-50 (bispectral index). When the BIS is between 40-50, 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.
- Post-operative nausea and vomiting (PONV) [ Time Frame: 1 day ]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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135157
|Contact: CANER GENÇ, MD||05444846865 ext +firstname.lastname@example.org|
|Contact: GÖKÇE ŞENOCAK, MD||05449771624 ext +email@example.com|
|Ondokuz Mayıs University Faculty of Medicine||Recruiting|
|Samsun, Turkey, 55270|
|Contact: Sezen Akgürel 05432498536 ext +9 firstname.lastname@example.org|
|Study Director:||CENGİZ KAYA, MD||Ondokuz Mayıs University Faculty of Medicine|