NCT05080985

Brief Summary

The study is planned to be a single-center randomized, prospective double-blind study and includes patients who planned to be done unilateral MRM (modified radical mastectomy) operation in Istanbul University Istanbul Faculty of Medicine. The objective of this study is to compare postoperative analgesic efficacies of TPVB (thoracic paravertebral block) and ESPB (erector spinae plane block) performed under ultrasound (USG) guidance after MRM. Primary outcome of this study is postoperative 24-hour morphine consumption whereas secondary outcomes were planned as the comparison of changes in hemodynamic parameters and numeric rating pain score (NRS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable postoperative-pain

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

November 20, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2021

Completed
Last Updated

October 18, 2021

Status Verified

October 1, 2021

Enrollment Period

1.3 years

First QC Date

September 15, 2021

Last Update Submit

October 4, 2021

Conditions

Postoperative Pain

Keywords

Acute postoperative painNerve blockThoracic wall

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    amount of postoperative 24 hours morphine consumption

    postoperative 24 hours

Secondary Outcomes (5)

  • Static and dynamic pain score assessed with Numeric Rating Scale (NRS).

    postoperative 24 hours

  • intraoperative heart rate

    during surgery

  • intraoperative mean arterial pressure

    during surgery

  • nause and vomit

    postoperative 24 hours

  • number of blocked dermatome

    30 minutes after block

Study Arms (2)

Group P : TPVB

EXPERIMENTAL

Thoracic paravertebral block

Procedure: TPVBDrug: Bupivacain

Group E : ESPB

EXPERIMENTAL

Erector spinae plane block

Procedure: ESPBDrug: Bupivacain

Interventions

TPVBPROCEDURE

20 ml 0.375 % bupivacaine was injected between superior costotransverse ligament and pleura.

Group P : TPVB
ESPBPROCEDURE

20 ml 0.375 % bupivacaine was injected between deep fascia of the erector spinae muscle and transverse process.

Group E : ESPB
BupivacainDRUG

20 ml 0.375 % bupivacaine was injected

Group E : ESPBGroup P : TPVB

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • unilateral MRM
  • ages 18-75 years
  • American Society of Anesthesiologists (ASA) classification I-III

You may not qualify if:

  • presence of contraindications for using regional anesthesia (not having patient approval, presence of bleeding-clotting disorders, infection at the injection site, local anesthetic allergy)
  • chronic analgesic use
  • diabetes mellitus
  • body mass index of (BMI) \> 35 kg/m2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University, Istanbul Faculty of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (1)

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PMID: 27501016BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nükhet Sivrikoz

    Attending anesthesiologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist

Study Record Dates

First Submitted

September 15, 2021

First Posted

October 18, 2021

Study Start

November 20, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

October 18, 2021

Record last verified: 2021-10

Locations

TU(1)