Breast Cancer Clinical Trial
Official title:
Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy
Verified date | February 2024 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare the total morphine consumption in the first 24 hour postoperative between combined modified pectoralis block (PECS II) and transversus plane block versus erector spinae block in modified radical mastectomy.
Status | Completed |
Enrollment | 60 |
Est. completion date | November 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Age 18: 60 years old - ASA (American Society of Anesthesiologists) physical status I II - Female patients scheduled for modified radical mastectomy Exclusion Criteria: - Patient refusal or inability to give informed consent - Subjects with a medical contraindication to regional anesthesia , such as coagulopathy, local infection or an allergy to local anesthetic - Body mass index (BMI) >35 - Presence of psychiatric diseases - History of chronic chest wall pain or neuropathic disorders - Alcohol or drug abuse - Severe chest wall deformities |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The total morphine consumption postoperative (mg) | Morphine consumption in mg | The first 24 hours postoperative. | |
Secondary | Postoperative pain score by Verbal numeric rating scale | Verbal numeric rating scale (VNRS) for postoperative pain monitoring using 11-point where zero equals no pain and 10 equals the worst pain imaginable. | 0, 2, 4, 8, 12, 24 hours postoperatively. | |
Secondary | Time to first request analgesia postoperative (min) | Time from postoperative period to time of first analgesic request in minutes | The first 24 hours postoperatively | |
Secondary | Postoperative level of IL6 (interleukin 6) (pg/mL) | Preoperative baseline and postoperative levels of IL6 will be measured (pg/mL) | Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative | |
Secondary | Arterial blood gas: Arterial blood gas: Arterial blood gases | Oxygen (mmHg) and carbon dioxide (mmHg) | Before surgery and 24 hours postoperative. |
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