Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Fujian Provincial Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- The quality of recovery
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
group control
group control :Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
Intervention: 0.9% Nacl (Drug)
group SPB
group SPB:Before induction of intravenous anesthesia, patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
The quality of recovery
Time Frame: 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 Outcomes
- Postoperative pain intensity(at postoperative hours 0.5, 1, 2, 4, 8 and 24)
Investigators
Yao Yusheng
Associate professor
Fujian Provincial Hospital