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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06436599
Other study ID # Medeniyet University
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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