Anesthesia
Conditions
Keywords
Ultrasound, Serratus Plane Block, Quality of recovery
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).
Interventions
DRUGRopivacaine
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.
DRUG0.9% Nacl
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
Sponsors
Fujian Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The quality of recovery | at 24 hours after surgery | The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | at postoperative hours 0.5, 1, 2, 4, 8 and 24 | Postoperative pain intensity was rated at postoperative hours 0.5, 1, 2, 4, 8 and 24 with Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 means no pain and 10 is the worst pain imaginable. |
Countries
China
Outcome results
None listed