Clinical trial NCT03903224: Combined PECS II and Transversus Plane Blocks Versus Erector Spinae Block in Modified Radical Mastectomy
Official title: Effect of Combined Modified Pectoralis and Transversus Plane Blocks Versus Erector Spinae Block on Postoperative Analgesia Following Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Acute Postoperative Pain
Keywords: Breast Cancer
Regional Anaesthesia
Morphine Consumption
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-04-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Breast cancer is the most common malignancy in women in the United States and is second only to lung cancer as a cause of cancer death. Breast surgery is commonly performed as a part of the management of breast cancer, is associated with considerable acute postoperative pain. Ultrasound guided Regional anesthesia is recommended to be a part of multimodal analgesia in order to manage the acute post-operative pain. New techniques are proposed to give adequate control of postoperative analgesia with less opioid needs in the first day postoperative. They include pectoralis nerve modified pectoralis, and erector spinae blocks.

The investigators will compare Modified pectoralis nerve block (Pecs II) plus transversus thoracic muscle plane (TTP) block versus Erector spinae block on morphine consumption during first 24 h following modified radical mastectomy.

Eligibility criteria: 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

Primary outcomes:
measure: The total morphine consumption postoperative (mg)
timeFrame: The first 24 hours postoperative.
Secondary outcomes:
measure: Postoperative pain score by Verbal numeric rating scale
timeFrame: 0, 2, 4, 8, 12, 24 hours postoperatively.
measure: Time to first request analgesia postoperative (min)
timeFrame: The first 24 hours postoperatively
measure: Postoperative level of IL6 (interleukin 6) (pg/mL)
timeFrame: Two blood samples will be withdrawn from the patient. The first one is immediately preoperative and the second one after 24 hours postoperative
measure: Arterial blood gas: Arterial blood gas: Arterial blood gases
timeFrame: Before surgery and 24 hours postoperative.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
Study officials:
affiliation: Assiut University
name: Eman A Ismail, A Lectuer
role: STUDY_DIRECTOR
References:
citation: 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.