NCT04796363

Brief Summary

Prospective interventional study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

November 24, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

November 25, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2022

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed
Last Updated

April 11, 2022

Status Verified

April 1, 2022

Enrollment Period

1.1 years

First QC Date

November 24, 2020

Last Update Submit

April 3, 2022

Conditions

AnalgesiaBreast Cancer

Keywords

Erector spinae plane blockUltrasound guidedBreast cancer surgeryNatural killer cellsAnalgesiaspread

Outcome Measures

Primary Outcomes (1)

  • Analgesic efficacy of ESPB

    Analgesic efficacy of Erector Spinae plabe block by measuring visual analogue scale which ranges from 0 to 10. 0 indicates no pain and 10 indicates maximum imaginable pain

    Up to 24 postoperative hours

Secondary Outcomes (2)

  • Spread of the injected dye in Erector Spinae plane

    Patients will be imaged 15 minutes after the block and before induction of general anaesthesia and surgery.

  • Dermatomal sensory coverage of ESPB

    Assessment will be done bilaterally every 3 minutes for 15 minutes after ESPB.

Other Outcomes (1)

  • Immunomodulation of ESPB

    Before ESPB and 24 hours after the block.

Study Arms (3)

ESPB Bubivacaine 0.25%

EXPERIMENTAL

20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 20 ml bupivacaine 0.25 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.

Procedure: Erector Spinae Plane Block with Bubivacaine

ESPB Bubivacaine 0.125%

ACTIVE COMPARATOR

20 patients will receive US-guided deep ESPB block before induction of general anaesthesia using 40 ml bupivacaine 0.125 % and 5 ml of radiocontrast dye (Omnipaque) at the level of T4.

Procedure: Erector Spinae Plane Block with Bubivacaine

No ESPB

PLACEBO COMPARATOR

20 patients will undergo standard general anaesthesia as a control group and postoperative analgesia with intravenous morphine patient controlled analgesia (PCA) and rescue analgesia if required.

Procedure: Standard General Anaesthesia

Interventions

Erector Spinae Plane Block with BubivacainePROCEDURE

Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery

ESPB Bubivacaine 0.125%ESPB Bubivacaine 0.25%
Standard General AnaesthesiaPROCEDURE

Standard General Anaesthesia without ESPB

No ESPB

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • Patient refusal.
  • Allergy or contraindication to any of the studied medications or anaesthetic agents.
  • Chronic opioid analgesic use.
  • Pregnancy.
  • Morbid obesity (BMI ≥ 40 kg/m2).
  • Scoliosis or any vertebral anomalies or previous spinal surgeries.
  • Infection at the site of injection or any other contraindication for regional anaesthesia.
  • Duration of surgery more than 90 minutes.
  • Renal impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Institute, Alexandria University

Alexandria, 21561, Egypt

Location

Related Publications (1)

  • Abdella AMMR, Arida EEAEM, Megahed NA, El-Amrawy WZ, Mohamed WMA. Analgesia and spread of erector spinae plane block in breast cancer surgeries: a randomized controlled trial. BMC Anesthesiol. 2022 Oct 17;22(1):321. doi: 10.1186/s12871-022-01860-w.

    PMID: 36253729DERIVED

MeSH Terms

Conditions

AgnosiaBreast Neoplasms

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Emad Eldin Abd El Monem Arida, Professor

    University of Alexandria

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 24, 2020

First Posted

March 12, 2021

Study Start

November 25, 2020

Primary Completion

January 11, 2022

Study Completion

January 21, 2022

Last Updated

April 11, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
starting 6 months after publication

Locations

EG(1)