The Efficacy of SPSIPB on Postoperative Pain in Patients Undergoing Reduction Mammoplasty Surgery: Case Series

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05901116
• Other study ID #: SPSIPB on mammoplasty
• Status: Completed
• Phase: N/A
• Start date: May 18, 2023
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Serratus posterior superior intercostal plane block (SPSIPB)
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.

Locations

Country	Name	City	State
Turkey	Sivas Cumhuriyet University	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Postoperative 24 hours
Primary	Total Tramadol consumption	Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.	Postoperative 24 hours
Secondary	Resque analgesic need	Total paracetamol need was recorded as "milligram" in unit despite of tramadol administration.	Postoperative 24 hours
Secondary	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.	Postoperative 24 hours