Back to resultsThe Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
Primary Purpose
Post Operative Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serratus posterior superior intercostal plane block (SPSIPB)
Sponsored by
About this trial
This is an interventional other trial for Post Operative Pain focused on measuring serratus posterior superior intercostal plane block, postoperative pain, reduction mammoplasty, regional anesthesia
Eligibility Criteria
Inclusion Criteria: Adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification. Exclusion Criteria: Patients who did not give consent, patients with coagulopathy, patients with signs of infection at the block application site, patients using anticoagulants, patients with local anesthetic drug allergies, patients with unstable hemodynamics, patients who could not cooperate during postoperative pain assessment
Sites / Locations
- Sivas Cumhuriyet University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SPSIPB
Arm Description
SPSIPB is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. Tramadol (intravenous analgesic drug) at a concentration of 4 mg per 1 ml was administered with patient-controlled analgesia (PCA) device (max dose: 400 mg /day)
Outcomes
Primary Outcome Measures
Numerical rating scale (NRS) scores
Numerical rating scale was used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Total Tramadol consumption
Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.
Secondary Outcome Measures
Resque analgesic need
Total paracetamol need was recorded as "milligram" in unit despite of tramadol administration.
Quality of Recovery scores
Quality of recovery-15 (QoR15) scale was used for the assessment of patients satisfaction. The scores of QoR15 changes between 0 to 150 points. 0 point means "there is no satisfaction." Higher scores mean indicating a good quality of recovery and better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05901116
Brief Title
The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
Official Title
The Efficacy of Serratus Posterior Superior Intercostal Plane Block (SPSIPB) on Postoperative Pain and Total Analgesic Consumption in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
May 18, 2023 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to investigate the postoperative analgesic efficacy of SPSIPB and its effect on opioid consumption in patients undergoing reduction mammoplasty.
Detailed Description
Ten patients had serratus posterior superior intercostal plane block (SPSIPB) as the intervention. Patients had SPSIPB with 0.25% bupivacaine (total volume of 30 ml) before the surgery in operating room. Numerical rating scale (NRS) was used to assess postoperative pain on 1st, 6th, 12th and 24th hour after the surgery. Total tramadol consumption was calculated by using patient-controlled analgesia (PCA) device. Patient satisfaction was assessed by using quality of recovery-15 (QoR15) scale. Paracetamol was planned as resque analgesic drug (maximum dose: 3 gr/day).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
serratus posterior superior intercostal plane block, postoperative pain, reduction mammoplasty, regional anesthesia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPSIPB
Arm Type
Other
Arm Description
SPSIPB is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle. Tramadol (intravenous analgesic drug) at a concentration of 4 mg per 1 ml was administered with patient-controlled analgesia (PCA) device (max dose: 400 mg /day)
Intervention Type
Other
Intervention Name(s)
Serratus posterior superior intercostal plane block (SPSIPB)
Intervention Description
Serratus posterior superior intercostal plane block is the intervention used in this study. It was performed when the patient is in lateral decubitis position. A high frequency (7-12 MHz) linear transducer of the ultrasound device is placed at the spinae scapula level in the transverse plane, and the upper medial border of the scapula, the trapezius muscle, rhomboid muscle, serratus posterior superior muscle (SPSM) and the second and third ribs are visualized. The sonovisible needle is then advanced immediately medial to the scapula, aiming for the area between the second and third ribs in order to reach the fascial plane between the SPSM and intercostal muscles. After contact of the needle with the rib gently, 1-2mL of saline is used to confirm the correct plane, and a total of 30 mL of 0.25% bupivacaine is administered to the superficial to the intercostal muscle.
Primary Outcome Measure Information:
Title
Numerical rating scale (NRS) scores
Description
Numerical rating scale was used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Time Frame
Postoperative 24 hours
Title
Total Tramadol consumption
Description
Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Resque analgesic need
Description
Total paracetamol need was recorded as "milligram" in unit despite of tramadol administration.
Time Frame
Postoperative 24 hours
Title
Quality of Recovery scores
Description
Quality of recovery-15 (QoR15) scale was used for the assessment of patients satisfaction. The scores of QoR15 changes between 0 to 150 points. 0 point means "there is no satisfaction." Higher scores mean indicating a good quality of recovery and better outcome.
Time Frame
Postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients older than 18 years of age who underwent reduction mammoplasty under general anesthesia and are American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Exclusion Criteria:
Patients who did not give consent,
patients with coagulopathy,
patients with signs of infection at the block application site,
patients using anticoagulants,
patients with local anesthetic drug allergies,
patients with unstable hemodynamics,
patients who could not cooperate during postoperative pain assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oğuz Gündoğdu
Organizational Affiliation
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sivas Cumhuriyet University
City
Sivas
ZIP/Postal Code
58000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36883093
Citation
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
Results Reference
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The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series
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