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

Primary Purpose

Breast Cancer, Postoperative Pain, Respiratory Function Impaired

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
RIB+SAP blocks
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Analgesia, postoperative pain, rhomboid intercostal block, serratus anterior plane block, respiratory function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Block Group

Control Group

Arm Description

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.

No block procedures will be performed in this group.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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 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.
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
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
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
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

Full Information

First Posted
August 10, 2022
Last Updated
April 15, 2023
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05547932
Brief Title
The Effect of Rhomboid Intercostal Block and Serratus Anterior Plane Block on Postoperative Respiratory Functions
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
April 13, 2023 (Actual)
Study Completion Date
April 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Postoperative Pain, Respiratory Function Impaired
Keywords
Analgesia, postoperative pain, rhomboid intercostal block, serratus anterior plane block, respiratory function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, controlled study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The patients will be under general anesthesia and will not know if they received a block procedure or not. The investigator, the data collector and the outcome assessor will be completely blind to the study groups. Only the care provider who will perform the block procedures will know the study groups.
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Block Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No block procedures will be performed in this group.
Intervention Type
Procedure
Intervention Name(s)
RIB+SAP blocks
Intervention Description
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 Outcome Measure Information:
Title
Forced Expiratory Volume in 1 second (FEV1)
Description
FEV1 of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Time Frame
postoperative 2nd hour
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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.
Time Frame
Postoperative second hour
Title
Postoperative opioid consumption
Description
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.
Time Frame
Postoperative 24th hour
Title
Forced Vital Capacity (FVC)
Description
FVC value of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Time Frame
postoperative 2nd hour
Title
FEV1/FVC
Description
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
Time Frame
postoperative 2nd hour
Title
forced expiratory flow at 25-75% of forced vital capacity (FEF25-75)
Description
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
Time Frame
postoperative 2nd hour
Title
Peak expiratory flow (PEF)
Description
PEF values of the patients in the block group will be higher at the postoperative second hour than the patients in the control group
Time Frame
postoperative 2nd hour

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bakiye Uğur, MD
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Study Chair
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Muğla
ZIP/Postal Code
48000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with anyone

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

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