Clinical trial NCT02103946: Serratus Anterior Plane Block Versus Paravertebral Block for Postmastectomy Analgesia
Official title: Serratus Anterior Muscle Plane Block Versus Paravertebral Block for Breast Cancer Resections.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Acute Pain
Keywords: serratus
paravertebral
breast
cancer
axilla
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2014-04-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ًًًُُُُThe investigators are testing the efficacy of a new novel technique; serratus anterior plane block, for preventing postoperative pain after breast surgery for cancer. This block will be compared with the well-established paravertebral block.

Detailed description: Paravertebral block (PVB) can be considered as a well-established option to provide anesthesia and postoperative analgesia during breast surgery. For patients receiving a PVB alone or in combination with general anesthesia significant lower resting, evoked and worst pain scores compared with other analgesic treatment strategies indicating that a PVB provides improved postoperative pain control in patients undergoing breast surgery. Furthermore, there might be a reduced need for postoperative opioid requirements and consecutively a decrease in opioid-induced adverse effects in patients receiving a PVB. Anyways there are always fear of pleural injury and pneumothorax in addition to epidural and intrathecal spread of the block. A novel newly introduced field block has been described recently to block the hemithorax under ultrasound guidance that is the Serratus Anterior Muscle Plane SAM block. Still this technique to the investigators knowledge is not tried in randomized clinical studies. The aim of this study is to find out that this new technique is comparable to PVB in patients undergoing breast surgeries with or without axillary node dissection.

Eligibility criteria: Inclusion Criteria:

* unilateral mastectomy with or without axillary lymph node dissection.
* American Society of Anesthesia (ASA) I\&II

Exclusion Criteria:

* morbid obesity (body mass index \> 40 kg/m2);
* renal insufficiency (creatinine \> 1.5 mg/dL),
* current chronic analgesic therapy (daily use \> 4 weeks),
* a history of opioid dependence, pregnancy,
* inability to communicate with the investigators or hospital staff,
* American Society of Anesthesia (ASA) III-IV

Primary outcomes:
measure: pain relief
timeFrame: first postoperative day
Secondary outcomes:
measure: opioid consumption
timeFrame: intraoperative and first postoperative day
Other outcomes:
measure: patient satisfaction
timeFrame: first week after surgery
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
state: Kasr Alainy
Study officials:
affiliation: Lecturer of anesthesia & pain relief
name: Ghada MN Bashandy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnabel A, Reichl SU, Kranke P, Pogatzki-Zahn EM, Zahn PK. Efficacy and safety of paravertebral blocks in breast surgery: a meta-analysis of randomized controlled trials. Br J Anaesth. 2010 Dec;105(6):842-52. doi: 10.1093/bja/aeq265. Epub 2010 Oct 14.
citation: Mendoza TR, Chen C, Brugger A, Hubbard R, Snabes M, Palmer SN, Zhang Q, Cleeland CS. The utility and validity of the modified brief pain inventory in a multiple-dose postoperative analgesic trial. Clin J Pain. 2004 Sep-Oct;20(5):357-62. doi: 10.1097/00002508-200409000-00011.
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.