NCT06899841

Brief Summary

to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

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

October 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 28, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 28, 2025

Status Verified

March 1, 2025

Enrollment Period

1 year

First QC Date

March 16, 2025

Last Update Submit

March 21, 2025

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

  • postoperative analgesic duration

    postoperative analgesic duration with each dose

    24 hours

Secondary Outcomes (3)

  • Pain score

    24 hours

  • side effects

    24 hours

  • dynamic pain score

    24 hours

Study Arms (3)

low dose dex

EXPERIMENTAL

0.5 mic/kg of dexmedetomidine administered

Drug: Dexmedetomidine

intermediate dose dex

EXPERIMENTAL

0.75 mic/kg of dexmedetomidine administered

Drug: Dexmedetomidine

high dose dex

EXPERIMENTAL

1 mic/kg of dexmedetomidine administered

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

different doses of dexmedetomidine added to bupivacaine in erector spinae plane block

high dose dexintermediate dose dexlow dose dex

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 70 years.
  • Both sexes, males and females.
  • Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
  • Body mass index (BMI) of 18-35 kg/m2
  • Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.

You may not qualify if:

  • Patients under 18 years.
  • Patient refusal of nerve block.
  • Infection at the site of injection.
  • Coagulopathy.
  • Allergy to used medications.
  • Psychiatric disorder or chronic pain syndromes.
  • Chronic opioid use or substance abuse.
  • Quadriplegic patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospitals

Asyut, Assiut Governorate, 71111, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
dr

Study Record Dates

First Submitted

March 16, 2025

First Posted

March 28, 2025

Study Start

October 1, 2024

Primary Completion

October 1, 2025

Study Completion

April 1, 2026

Last Updated

March 28, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)