NCT07034300

Brief Summary

This study compares lidocaine alone vs. lidocaine with dexmedetomidine in Intravenous regional anesthesia (IVRA) for upper limb surgery in terms of pain scores and duration of analgesia

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_4 postoperative-pain

Timeline
Completed

Started May 2025

Shorter than P25 for phase_4 postoperative-pain

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

May 21, 2025

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 21, 2025

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

3 months

First QC Date

June 15, 2025

Last Update Submit

June 15, 2025

Conditions

Keywords

Intravenous Regional AnesthesiaLidocaineDexmedetomidinePainUpper Limb SurgeryBier Block

Outcome Measures

Primary Outcomes (1)

  • Duration of Postoperative Analgesia

    Time from surgery to first request for pain relief

    Up to 24 hours post surgery

Secondary Outcomes (1)

  • Pain Score according to Visual Analogue Scale (VAS)

    2 hours post-operation

Study Arms (2)

Lidocaine

ACTIVE COMPARATOR

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine

Drug: Lidocaine (drug)

Lidocaine with Dexmedetomidine

EXPERIMENTAL

Intravenous Regional Anesthesia with 40 ml of 0.5% lidocaine + dexmedetomidine (0.5 μg/kg)

Drug: Lidocaine (drug)Drug: Dexmedetomidine

Interventions

40 ml of 0.5% lidocaine

LidocaineLidocaine with Dexmedetomidine

Dexmedetomidine (0.5 μg/kg)

Lidocaine with Dexmedetomidine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiology Status I
  • American Society of Anesthesiology Status II
  • Elective surgery
  • Surgery duration \<45 minutes

You may not qualify if:

  • Sleep apnea
  • BMI \>30
  • Heart block
  • uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Fatima Memorial Hospital

Lahore, Punjab Province, 55000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

LidocainePharmaceutical PreparationsDexmedetomidine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Muhammad M Younas, MBBS

    Fatima Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad M Younas, MBBS

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2025

First Posted

June 24, 2025

Study Start

May 21, 2025

Primary Completion

August 21, 2025

Study Completion

August 31, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to institutional policy and data privacy considerations. The data are not intended for secondary use beyond the scope of this study.

Locations