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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05911373
Other study ID # ataunibreastanalgesia
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 21, 2023
Est. completion date January 15, 2024

Study information

Verified date March 2024
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Mastectomy is a technique often used in breast cancer surgery. Patients experience moderate to severe pain postoperatively after this procedure. Various plane blocks, NSAIDs, and opioid analgesics can be administered to these patients as components of multimodal analgesia. In the the study, the investigators aimed to evaluate the analgesic effects of the serratus plane block, the parasternal block added to the serratus plane block, and the dermatomal differences.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date January 15, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. American Society of Anesthesiologist's physiologic state I-III patients 2. To undergo Mastectomy Surgery 3. Being between the ages of 18-65 years Exclusion Criteria: - Having a known heart, kidney, liver or hematological disease - Having a history of peptic ulcer, gastrointestinal bleeding, allergy, chronic pain - Routine analgesic use and history of analgesic use in the last 24 hours - Not willing to participate in the study - Uncooperative patients who have coagulopathy or use anticoagulant drugs - To be allergic to one of the drugs to be used

Study Design


Related Conditions & MeSH terms


Intervention

Other:
group serratus plan block
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml saline
group serratus and parasternal plan block
preoperativelly, Superficial Serratus Block performed with 30 ml %0.25 Bupivacaine and Parasternal Block performed with 10 ml %0.25 Bupivacaine

Locations

Country Name City State
Turkey Ali Ahiskalioglu Erzurum

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Hu NQ, He QQ, Qian L, Zhu JH. Efficacy of Ultrasound-Guided Serratus Anterior Plane Block for Postoperative Analgesia in Patients Undergoing Breast Surgery: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Pain Res Manag. 2021 Oct 25;2021:7849623. doi: 10.1155/2021/7849623. eCollection 2021. — View Citation

Piraccini E, Biondi G, Corso RM, Maitan S. The use of rhomboid intercostal block, parasternal block and erector spinae plane block for breast surgery. J Clin Anesth. 2020 Feb;59:10. doi: 10.1016/j.jclinane.2019.06.004. Epub 2019 Jun 6. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative opioid consumption First 24 hours total fentanyl consumption with patient controlled analgesia first 24 hours
Secondary Visual analog pain score Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score First 24 hours
Secondary Sensory Assessment Sensory Assessment will be performed on patients following the block procedure with pinprick test. 24 hours
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