Pain, Postoperative Clinical Trial
Official title:
Analgesic Efficiency of Superficial Serratus Plane Block for Modified Radical Mastectomy and Axillary Lymph Node Disection: Randomized Controlled Study
Verified date | November 2017 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Breast cancer is the most common type of cancer in women. Mastectomy and axillary lymph node
disection are commonly performed as part of the cancer management. This surgery can cause
significant postoperative pain. The serratus plane block (SPB) has been described for
analgesia of the hemithorax and reported for many cases such as thoracoscopy, shoulder
arthroscopy, breast surgery and axillary lymph node dissections. Serratus plane block may be
a viable alternative to current regional anaesthetic techniques such as thoracic
paravertebral and central neuraxial blockade.
The aim of this study is to determine effectiveness of ultrasound guided superficial serratus
plane block in patients undergoing modified radical mastectomy and axillary lymph node
dissection surgery.
Status | Completed |
Enrollment | 48 |
Est. completion date | August 1, 2017 |
Est. primary completion date | March 1, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - American Society of Anesthesiologist's physiologic state I-III patients undergoing Modified Radical Mastectomy and Axillary Lymph Node Disection Exclusion Criteria: - chronic pain, bleeding disorders, renal or hepatic insufficiency,patients on chronic non-steroidal anti-inflammatory medications |
Country | Name | City | State |
---|---|---|---|
Turkey | Regional Training and Research Hospital | Erzurum |
Lead Sponsor | Collaborator |
---|---|
Ataturk University |
Turkey,
Ahiskalioglu A, Alici HA, Yayik AM, Celik M, Oral Ahiskalioglu E. Ultrasound guided serratus plane block for management of acute thoracic herpes zoster. Anaesth Crit Care Pain Med. 2017 Oct;36(5):323-324. doi: 10.1016/j.accpm.2017.01.008. Epub 2017 Mar 21. — View Citation
Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid Consumption | First 24 hours total fentanyl consumption with patient controlled analgesia | First 24 hours total opioid consumption | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively. | postoperative first hour | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively. | postoperative second hour | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively. | postoperative 4th hour | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively. | postoperative 8th hour | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively. | postoperative 12th hour | |
Secondary | Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively. | postoperative 24th hour |
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