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Completed

NCT Number: NCT05547932

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RIB+SAP blocks

Procedure

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

Primary outcomes

  1. Forced Expiratory Volume in 1 second (FEV1)

    Time frame: postoperative 2nd hour

    FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

Secondary outcomes

  1. Postoperative pain

    Time frame: Postoperative second hour

    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.

  2. Postoperative opioid consumption

    Time frame: Postoperative 24th hour

    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.

  3. Forced Vital Capacity (FVC)

    Time frame: postoperative 2nd hour

    FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

  4. FEV1/FVC

    Time frame: postoperative 2nd hour

    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

  5. forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)

    Time frame: postoperative 2nd hour

    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

  6. Peak expiratory flow (PEF)

    Time frame: postoperative 2nd hour

    PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Acronym: RIBSAB

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 21, 2022
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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