NCT07640516

Brief Summary

The aim of this study is to compare the analgesic efficacy and safety of dexmedetomidine versus fentanyl as adjuvants to bupivacaine in ultrasound-guided combined supra-inguinal fascia iliaca and proximal sciatic nerve blocks used as a solo anesthetic technique in high-risk patients undergoing unilateral above knee amputation.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Jul 2026

Shorter than P25 for not_applicable

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 Progress13%
Jul 2026Mar 2027

First Submitted

Initial submission to the registry

May 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 10, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 13, 2026

Status Verified

May 1, 2026

Enrollment Period

6 months

First QC Date

May 28, 2026

Last Update Submit

July 10, 2026

Conditions

Analgesia AssessmentAbove Knee AmputationFentanyl vs Dexmedetomidine

Keywords

dexmedetomidine vs fentanyl PNBs AKA

Outcome Measures

Primary Outcomes (1)

  • Time to the first request for the rescue analgesia

    the first time the patient needs analgesia postoperative

    24 hours postoperative

Secondary Outcomes (6)

  • Total morphine consumption postoperative.

    24 hours postoperative

  • Intraoperative Pain score (VAS).

    from block performance till 24 hours postopertaive

  • Patient satisfaction

    24 hours postoperative

  • intraoperative heart rate

    intraoperative

  • Complications ( nausea - vomiting - bradycardia - hypotension .... )

    24 hours post operative

  • +1 more secondary outcomes

Study Arms (2)

dexmedetomidine group

ACTIVE COMPARATOR

patients receiving peripheral nerve blocks for above-knee amputation with dexmedetomidine added to the local anesthetic solution

Drug: Dexmedetomidine

fentanyl group

ACTIVE COMPARATOR

patients receiving peripheral nerve blocks for above-knee amputation with fentanyl added to the local anesthetic solution

Drug: Fentanyl (as Citrate)

Interventions

Fentanyl (as Citrate)DRUG

Fentanyl added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

fentanyl group
DexmedetomidineDRUG

Dexmedetomidine added as an adjuvant to the local anesthetic solution during peripheral nerve block for above-knee amputation surgery.

dexmedetomidine group

Eligibility Criteria

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

You may qualify if:

  • \- Age ≥18 years
  • Both sexes
  • ASA III-IV
  • Documented cardiac disease (e.g., EF \< 40%, NYHA II or higher)
  • Documented pulmonary disease (e.g., COPD with FEV1 \< 60%)
  • Scheduled for above-knee amputations

You may not qualify if:

  • Neurological or intellectual disability
  • Drug abuse
  • Allergy to study drugs
  • Pregnancy
  • Contraindications to regional anesthesia (e.g., coagulopathy, local infection)
  • Significant renal or hepatic impairment( plts \<75000 or INR \>1.5)
  • Current anticoagulant therapy
  • severe haemodynamically unstability at the time of block performance, defined as map \> 65 mmhg but achieved by high-dose vasopressors (e.g., norepinephrine ≥ 0.1 mcg/kg/min) after fluid ressuscitation .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KasrELainiH

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

DexmedetomidineFentanyl

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperidines

Central Study Contacts

paula atef gobran kamil, MBBCH, M.SC

CONTACT

0201276604277paula.atef.gobran.1995@gmail.com

tamer ibrahem rouk, MD

CONTACT

01006216826tamer_rouk@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor of anesthesiology

Study Record Dates

First Submitted

May 28, 2026

First Posted

June 10, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)