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Completed

NCT Number: NCT02691195

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

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.

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Key information

Conditions

Anesthesia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ropivacaine

Drug

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.

Other names: local anesthetic

0.9% NaCl

Drug

patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.

Other names: Normal saline

Primary outcomes

  1. 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

  1. Postoperative pain intensity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fujian Provincial Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 25, 2016
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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