Skip to main content
OpenTrials
Completed

NCT Number: NCT06436599

SPSIPB Versus Deep SAPB for Analgesia After Breast Surgery

The application of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement. Therefore, we aimed to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Professor Doctor Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

About this study

Breast surgery is one of the most common operations performed by General Surgery and may be associated with acute postoperative pain. Acute postoperative pain is an independent risk factor for the development of chronic pain after mastectomy. Various regional anaesthetic procedures have been tried to achieve better acute pain control and thus less chronic pain. The use of regional anaesthetic procedures in breast surgery is associated with a lower incidence of chronic pain, reduced morbidity, shorter hospital stay and less opioid requirement.

Interfascial plane blocks have become popular because they are easy to perform and safe. Since interfascial plan blocks are based on the injection of local anaesthetic between two fasciae, the complication rate such as nerve damage is very low. With this method, effective analgesia can be provided in various areas such as abdominal, thoracic and lumbar regions while reducing opioid consumption and avoiding neuraxial methods.

In randomised controlled trials investigating the efficacy of Serratus Anterior Plane Block for postoperative analgesia management after breast surgery, adequate analgesia was reported.

Serratus posterior superior intercostal plan block, a newly defined interfascial plan block, has been shown to provide a wide sensory blockade between intercostal muscles. Postoperative analgesic efficacy has been demonstrated in thoracic, breast and shoulder surgeries.

The aim of our study was to compared the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • unilateral mastectomy(modified radial mastectomy)
  • ASA I-III risk group

Exclusion criteria

  • Coagulopathy
  • Wound and infection in the block area
  • Local anaesthetic allergy
  • Mental retardation
  • Non-cooperative
  • Pregnant patients

Treatment and study plan

plane block with %0.25 30 ml bupivacaine

Other

evaluation of the efficacy of two different plan blocks for postoperative analgesia

Other names: postoperative analgesia

Primary outcomes

  1. Evaluation of analgesic efficacy of postoperative plan blocks with numerical pain score (NRS)

    Time frame: within 24 hours postoperative

    Evaluation of which of the two plan blocks is more effective in postoperative analgesia.

    Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 1. hour, 4. hours, 8. hours, 12. hours and 24. hours. A lower numeric pain scale indicates a lower level of pain.

Secondary outcomes

  1. Comparison of tramadol(mg) consumption

    Time frame: within 24 hours postoperative

    Using a patient-controlled analgesia device, tramadol consumption and total tramadol consumption will be compared between 0-1st hour, 1st-4th hour, 4th-8th hour, 8th-12th hour, 12th-24th hour postoperatively..

  2. perioperative remifentanil consumption

    Time frame: perioperative

    The amounts (mcg) of remifantanil consumed during the surgical procedure will be compared

  3. rescue anesthesia

    Time frame: within 24 hours postoperative

    In the postoperative 24-hour period, tenoxicam will be administered and recorded as rescue analgesia to patients who feel pain despite patient-controlled nalgesia (tramadol).

  4. postoperative nausea-vomiting (PONV)

    Time frame: within 24 hours postoperative

    The number of times of nausea and vomiting in the postoperative period will be recorded and compared in both patient groups. A lower numerical value of postoperative nausea-vomiting indicates better patient comfort in the postoperative period.

  5. patient satisfaction (5-point Likert scale)

    Time frame: 24 hours after surgery

    At postoperative discharge, 5-point Likert satisfaction questionnaire will be administered to the patient. A high numerical value on a five-point Likert satisfaction scale indicates that the patient are satisfied with the procedure performed.

Sponsors and collaborators

Lead sponsor

Mustafa Burgac

Other

Registry information

Official study title

Comparison of Serratus Posterior Superior Intercostal Plane Block Versus Deep Serratus Anterior Plane Block for Postoperative Analgesia After Breast Surgery: a Prospective Randomized Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
May 19, 2026

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.

Published trials that share one or more normalized conditions with this study.