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Completed

NCT Number: NCT05901116

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

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sivas Cumhuriyet University

Sivas, 58000, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Serratus posterior superior intercostal plane block (SPSIPB)

Other

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 outcomes

  1. Numerical rating scale (NRS) scores

    Time frame: Postoperative 24 hours

    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.

  2. Total Tramadol consumption

    Time frame: Postoperative 24 hours

    Postoperative analgesic (tramadol) need was measured by using patient-controlled analgesia (PCA) device.

Secondary outcomes

  1. Resque analgesic need

    Time frame: Postoperative 24 hours

    Total paracetamol need was recorded as "milligram" in unit despite of tramadol administration.

  2. Quality of Recovery scores

    Time frame: Postoperative 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 13, 2023
Registry last updated
Jun 13, 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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