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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Postoperative Pain; Respiratory Function Impaired
• Intervention / Treatment: Procedure: RIB+SAP blocks

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey, 48000
    • Muğla Sıtkı Koçman University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• İnfection at the injection sites
• Known allergy to local anesthetics
• Known psychiatric diseases
• Operations longer than 3 hours

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Block Group; After endotracheal intubation, patients will be positioned in lateral decubitus position. A linear ultrasound probe will be placed at the edge of scapula at the level of T5-T6. Under sterile conditions, the landmark points (rhomboid major muscle, 5th and 6th ribs, and intercostal muscles) will be observed and a block needle will be directed to the interfacial plane between rhomboid major muscle and intercostal muscle. RIB will be performed by injecting 20 ml of bupivacaine 0.25%. In the same position, the probe will be placed at the midaxillary line at the level of T3, and the landmark points (latissimus dorsi muscle and serratus muscle and intercostal muscles) will be observed. Under sterile conditions, a SAP block will be performed by injecting 20 ml of Bupivacaine 0.25% into the plane between serratus muscle and intercostal muscle.	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.
No Intervention: Control Group; No block procedures will be performed in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: September 18, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 15, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Analgesia; postoperative pain; serratus anterior plane block; respiratory function; rhomboid intercostal block
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Respiratory Insufficiency
• Other Study ID Numbers: MSK8/22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with anyone

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No