Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05547932
Other study ID # MSK8/22
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 21, 2022
Est. completion date April 14, 2023

Study information

Verified date April 2023
Source Mugla Sitki Koçman University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Rhomboid intercostal block is used to block lateral cutaneous branches of intercostal nerves between T3 and T9 dermatomes. Serratus anterior plane block is used to block lateral cutaneous branches of intercostal nerves between T2 and T6, in addition, it is also known to block thoracodorsal nerve and long thoracic nerve. Both of the blocks are usually performed for postoperative analgesia following breast surgery. The primary hypothesis of the study is that FEV1 value of the patients who will receive modified radical mastectomy (MRM) and rhomboid intercostal plane (RIP) block combined with serratus anterior plane (SAP) will be higher than FEV1 value of the patients in the no-block group. The secondary hypothesis is that RIP+SAP blocks will provide reduction in the pain scores and opioid consumption in the postoperative first 24 hours.


Description:

The patients who are scheduled for MRM under general anesthesia, aged between 18-65 years and ASA scores I-II will be included in the study. Respiratory functions (FEV₁, FVC, FEV₁/FVC, PEF, FEF25-75) of the patients will be measured by a hand-held spirometry device prior to the operation in the surgical ward. The induction of anesthesia will be provided similarly in all patients, then patients will be intubated and randomly divided into two groups. One group will receive RIP+SAP block using 40 milliliters of %0.25 bupivacaine and patients in the control group will receive no block procedures. The standard analgesia will be provided by intraoperative intravenous (iv) infusion of dexketoprofen 50 mg and iv tramadol 1 mg/kg which will be administered in 15 minutes before end of the surgery. Respiratory functions of the patients will be measured at the postoperative 2nd, 4th and 24th hours. Pain intensity of the patients will be evaluated by Numerical Rating Scale (NRS) which is a scale ranges between 0 (no pain) and 10 (the worst pain that a person can stand). NRS scores will be evaluated at the postoperative 15th, 30th minutes and 1st, 2nd, 6th, 12th and 24th hours, and opioid consumption will be recorded at the postoperative 24th hour.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date April 14, 2023
Est. primary completion date April 13, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - ASA I-II patients - Female - Ages between 18-65 - Patients who will receive breast cancer surgery under general anesthesia Exclusion Criteria: - Known respiratory diseases - Rhinitis and atopic dermatitis story - New York Heart Association Class equal to higher than class 2 - Respiratory diseases story in the last two weeks - Alchol or substance or chronic opioid consumption story - Any pain killers intake in the last 24 hours prior to surgery - Active smokers or ex-smokers - Body mass index over 35 kg/m2 - Infection at the injection sites - Known allergy to local anesthetics - Known psychiatric diseases - Operations longer than 3 hours

Study Design


Intervention

Procedure:
RIB+SAP blocks
RIB block will be performed after endotracheal intubation, then a SAP block will be performed. No other intervention will be performed to the patients.

Locations

Country Name City State
Turkey Mugla Sitki Koçman University Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Forced Expiratory Volume in 1 second (FEV1) FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group postoperative 2nd hour
Secondary Postoperative pain The pain scores of the patients in the block group will be lower than the patients in the control group at the postoperative second hour. Postoperative second hour
Secondary Postoperative opioid consumption The opioid consumption of the patients in the block group will be lower than the patients in the control group at the postoperative 24th hour. Postoperative 24th hour
Secondary Forced Vital Capacity (FVC) FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group postoperative 2nd hour
Secondary FEV1/FVC FEV1/FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group postoperative 2nd hour
Secondary forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) FEF25-75 values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group postoperative 2nd hour
Secondary Peak expiratory flow (PEF) PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group postoperative 2nd hour
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A