Clinical trial NCT02691195: Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
Official title: Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Keywords: Ultrasound
Serratus Plane Block
Quality of recovery
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regional anesthesia improves quality of recovery after surgery in many studies. Ultrasound-guided serratus plane block is a novel technique which may be a viable alternative to current regional anesthetic techniques. This randomized, controlled trial is to examine the effects of ultrasound-guided serratus plane block anesthetic on the QoR after breast tumor resection.

Detailed description: A total of 72 subjects (36 patients for each groups) were enrolled in this study. Patients were allocated to either the general anesthesia group (group control) or SPB (serratus plane block) + general anesthesia groups (group SPB) using randomized central computer-generated sequence software (SAS 19.0). The allocation ratio was 1:1 for the two groups. Group assignment was concealed by opaque sticking envelops. The major research content is to evaluate the quality of recovery using 40 questionnaire (QoR-40).

Eligibility criteria: Inclusion Criteria:

* Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.

Exclusion Criteria:

* Patients with chronic ethanol
* long-term use of psychotropic drugs (e.g. sedative drugs and antidepressant);
* contraindications for serratus plane block including coagulopathy, infection at the puncture site;
* unable to cooperate with this research due to cognitive impairment, psychopathy or not willing for the hospital follow-up;
* administration of other test drugs or joining in other clinical study in 3 months before our study;
* received radiotherapy or chemotherapy before surgery;
* other conditions not allocated for this study out of the researchers' consideration.

Primary outcomes:
measure: The quality of recovery
timeFrame: at 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain intensity
timeFrame: at postoperative hours 0.5, 1, 2, 4, 8 and 24
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Yusheng Yao, PHD & MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.