NCT04218149

Brief Summary

Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started May 2019

Shorter than P25 for phase_4 breast-cancer

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

Study Start

First participant enrolled

May 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2019

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
Last Updated

January 31, 2020

Status Verified

April 1, 2019

Enrollment Period

5 months

First QC Date

January 3, 2020

Last Update Submit

January 29, 2020

Conditions

Breast CancerPostoperative Pain

Keywords

serratus plane block, erector spinae plane block, postoperative analgesia

Outcome Measures

Primary Outcomes (3)

  • Postoperative pain score

    Visual analog scale (0-10), \<4 is adequate analgesia

    Postoperative 24 hours

  • Postoperative tramadol consumption

    Postoperative opiodi consumption with patient controlled analgesia

    Postoperative 24 hours

  • Rescue analgesic

    If VAS score is 4 or more, paracetamol 1 gr is administered

    Postoperative 24 hours

Secondary Outcomes (1)

  • Analgesia time

    Procedure

Study Arms (2)

Group S

ACTIVE COMPARATOR

Serratus plane block with 25 ml %0.25 bupivacaine

Drug: Bupivacaine Injection

Grup E

ACTIVE COMPARATOR

Erector spinae plane block with 25 ml %0.25 bupivacaine

Drug: Bupivacaine Injection

Interventions

Bupivacaine InjectionDRUG

Block with bupivacaine

Group SGrup E

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I-II
  • Age: 18 - 65 years
  • unilateral breast surgery

You may not qualify if:

  • Does not approve the study
  • Pregnant
  • Emergency
  • ASA III-IV
  • History of local anesthetic allergy
  • Infection in the block area
  • Coagulation disorder
  • Morbid obesity (body mass index\> 40 kg / m²)
  • Severe organ failure
  • Previous neurological deficit
  • Psychiatric disease
  • History of chronic pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SBÜ Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast NeoplasmsPain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
research assistant

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 6, 2020

Study Start

May 1, 2019

Primary Completion

September 29, 2019

Study Completion

October 1, 2019

Last Updated

January 31, 2020

Record last verified: 2019-04

Locations

TU(1)