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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691195
• Other study ID #: K2016-1-07
• Status: Completed
• Phase: Phase 4
• First received: February 15, 2016
• Last updated: March 3, 2018
• Start date: March 15, 2016
• Est. completion date: June 14, 2017

Study information

• Verified date: March 2018
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: June 14, 2017
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Ropivacaine
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.
• 0.9% Nacl
patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The quality of recovery	The primary outcome was the quality of recovery, which was assessed at 24 hours after surgery using a 40-item questionnaire (QoR-40).	at 24 hours after surgery
Secondary	Postoperative pain intensity	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.	at postoperative hours 0.5, 1, 2, 4, 8 and 24