Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery

Analgesia Clinical Trial

Official title:

Comparison of Analgesic Efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in Breast Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06436599
• Other study ID #: Medeniyet University
• Status: Recruiting
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: Istanbul Medeniyet University
• Contact: Mustafa Burgaç
• Phone: 05389848198
• Email: mustafaburgac[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

Description:

Breast conserving 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 evaluate the postoperative analgesic efficacy of Serratus Anterior Plan Block and Serratus Posterior Superior Intercostal Plan Block in breast surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• unilateral 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

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• plane block with %0.25 30 ml bupivacaine
evaluation of the efficacy of two different plan blocks for postoperative anaesthesia

Locations

Country	Name	City	State
Turkey	Istanbul Professor Doctor Süleyman Yalçin City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Burgac

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	evaluation of anelgesic efficacy of postoperative plan blocks with numerical pain score	Evaluation of which of the two plan blocks is more effective in postoperative anaesthesia.; Postoperative pain scores will be evaluated with a numerical pain score. Evaluation will be performed postoperatively at 30. minutes, 1. hour, 4. hours, 8. hours, 12. hours and 24. hours.	postoperative 24 hours
Secondary	postoperative used anelgesic quantity	Before the end of the surgical procedure, the patient will be administered 1 mg/kg tramadol and 1 g paracetamol.; Intra venous tramadol will be administered with a pain pump for pain control for 24 hours postoperatively.; The amount of tramadol used in both plane blocks will be compared.	postoperative 24 hours