NCT02691195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

March 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

1.2 years

First QC Date

February 15, 2016

Last Update Submit

March 3, 2018

Conditions

Anesthesia

Keywords

UltrasoundSerratus Plane BlockQuality of recovery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Postoperative pain intensity

    at postoperative hours 0.5, 1, 2, 4, 8 and 24

Study Arms (2)

group control

PLACEBO COMPARATOR

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.

Drug: 0.9% Nacl

group SPB

EXPERIMENTAL

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.

Drug: Ropivacaine

Interventions

RopivacaineDRUG

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

Also known as: local anesthetic
group SPB
0.9% NaclDRUG

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

Also known as: Normal saline
group control

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of American Society of Anesthesiologists' (ASA) Physical Status class I-II scheduled for first modified radical mastectomy were included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (2)

  • 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.

    PMID: 23923989BACKGROUND

  • Yao Y, Li J, Hu H, Xu T, Chen Y. Ultrasound-guided serratus plane block enhances pain relief and quality of recovery after breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2019 Jun;36(6):436-441. doi: 10.1097/EJA.0000000000001004.

    PMID: 31021882DERIVED

MeSH Terms

Interventions

RopivacaineAnesthetics, LocalSaline Solution

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Yusheng Yao, PHD & MD

    Fujian Provincial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 25, 2016

Study Start

March 15, 2016

Primary Completion

June 12, 2017

Study Completion

June 14, 2017

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)