NCT05727098

Brief Summary

Persistent pain after breast cancer surgery is frequently observed in more than 60% of patients.The suboptimal management of perioperative pain can lead to the occurrence of persistent breast cancer pain syndrome and phantom breast pain. Dexmedetomidine, a novel α2-agonist with an eight-fold affinity for α2-adrenergic receptors (sedate and analgesic effects) as clonidine, while exerts much less α1-effects., has been found to significantly increase the duration of peripheral nerve blocks, with minimal systemic side effects. Ketamine is a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptors. It is used for sedation, premedication, induction, and maintenance of general anesthesia. Central, regional, and local anesthetic and analgesic properties have been reported for ketamine. Both can be used through Erector spinae plane block for postoperative pain control.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2 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

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

June 8, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

February 3, 2023

Last Update Submit

June 7, 2023

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Time to first rescue analgesia request postoperative

    the time of first rescue analgesia

    24 hours

  • Total opioid consumption

    Total opioid consumption

    24 hours

Secondary Outcomes (1)

  • Visual analogue scale.

    24 hours

Study Arms (3)

Bupivacaine

ACTIVE COMPARATOR

Will receive ultrasound guided ESPB with 0,25% Bupivacaine .

Drug: Bupivacaine Hydrochloride

Bupivacaine and dexmedetomedine

ACTIVE COMPARATOR

Will receive ultrasound guided ESPB with 0,25% Bupivacaine + Dexmedetomidine.

Drug: Bupivacaine Hydrochloride and dexmedetomedine

Bupivacaine and Ketamine

ACTIVE COMPARATOR

will receive ultrasound guided ESPB with 0,25% Bupivacaine + Ketamine.

Drug: Bupivacaine Hydrochloride and ketamine

Interventions

Bupivacaine HydrochlorideDRUG

injection of Bupivacaine 0.25% in ESPB

Also known as: local anesthetic
Bupivacaine
Bupivacaine Hydrochloride and dexmedetomedineDRUG

injection of Bupivacaine 0.25% and dexmedetomedine in ESPB

Also known as: local anesthetic and dexmedetomedine
Bupivacaine and dexmedetomedine
Bupivacaine Hydrochloride and ketamineDRUG

injection of Bupivacaine 0.25% and ketamine in ESPB

Also known as: local anesthetic and ketamine
Bupivacaine and Ketamine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsgender identity only females
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II .
  • female aged between 18 to 65. Scheduled for elective modified radical mastectomy under general anesthesia.

You may not qualify if:

  • Patient known to have allergy to any of the drugs used in the study.
  • Infection at injection site.
  • Coagulation disorders.
  • severe heart ,liver or kidney disease.
  • Unwillingness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanafy

Cairo, 12588, Egypt

Location

Related Publications (1)

  • Hasoon J, Urits I, Viswanath O, Dar B, Kaye AD. Erector Spinae Plane Block for the Treatment of Post Mastectomy Pain Syndrome. Cureus. 2021 Jan 12;13(1):e12656. doi: 10.7759/cureus.12656.

    PMID: 33585141RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BupivacaineAnesthetics, LocalKetamine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAnestheticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ehab H Shaker, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesia, ICU and Pain management

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 14, 2023

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

June 8, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

After data publication upon request

Locations

EG(1)