The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions

Breast Cancer Clinical Trial

— RIBSAB  

Official title:

The Effect of Ultrasound-guided Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions and Analgesia After Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05547932
• Other study ID #: MSK8/22
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Pain, Postoperative
• Postoperative Pain
• Respiratory Function Impaired
• Respiratory Insufficiency

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