Ultrasound-guided Serratus Plane Block for the Quality of Recovery After Modified Radical Mastectomy

F

Fujian Provincial Hospital

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Ropivacaine
Drug: 0.9% Nacl

Study type

Interventional

Funder types

Other

Identifiers

NCT02691195
K2016-1-07

Details and patient eligibility

About

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.

Full 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).

Enrollment

72 patients

Sex

Female

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

72 participants in 2 patient groups, including a placebo group

group control
Placebo Comparator group
Description:
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.
Treatment:
Drug: 0.9% Nacl
group SPB
Experimental group
Description:
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.
Treatment:
Drug: Ropivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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