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Dexmedetomidine Versus Fentanyl As Adjuvants to Erector Spinae Plane Block for Postoperative Analgesia Following Simple Nephrectomy: a Randomized Clinical Trial

NCT06799442 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-01-29

No results posted yet for this study

Summary

The aim of this clinical trial is to compare the time to first analgesic request between dexmedetomidine and fentanyl as adjuvants in erector spinae plane block in patients undergoing simple nephrectomy .

• Secondary outcome Pain scores; Numerical Rating Scale (NRS) at rest and when coughing \[at 1, 2, 4, 8, 16 and 24 hours postoperatively.\] The total opiod dose in the first 24 hours postoperatively. Duration of analgesia is defined as duration between block administration and time of first analgesic request.

Any adverse effects related to anesthesia or the technique. Incidence of Postoperative nausea \& vomiting . Block related complication during and after block procedure till 24hours postoperatively (local anesthetic systemic toxicity, pneumothorax and vascular puncture during block procedure).

Intraoperative haemodynamics parameters MAP ,HR , co2 and SP O2 . Postoperative haemodynamics parameters MAP , HR and SP O2 \[at 1, 2, 4, 8, 16 and 24 hours postoperatively. \]

Conditions

  • Nephrectomy

Interventions

PROCEDURE

Erector Spinae Plane Block

Patients will be placed in lateral position with the surgical site upward. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. An echogenic needle needle will be inserted using an in-plane approach and craniocaudally direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging.

DRUG

Dexmedetomidine

50 mic dexmedetomidine which is diluted to 2ml.

DRUG

fentanyl

100 mic fentanylwhich is also diluted to 2 ml.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Moamen Mostafa Makkey, Doctor · Assiut University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-12-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06799442 on ClinicalTrials.gov