NCT06658418

Brief Summary

To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
7mo left

Started Nov 2024

Typical duration for phase_1

Status
not yet 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 Progress73%
Nov 2024Dec 2026

First Submitted

Initial submission to the registry

October 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 24, 2024

Last Update Submit

October 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • VAS score

    pain intensity using VAS score

    at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.

Secondary Outcomes (1)

  • the time for requirement of first morphine dose

    at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.

Study Arms (2)

dexmedetomidine combined with bupivacaine

ACTIVE COMPARATOR

use for Dexmedetomidine and bupivacain for erector spinae plane block

Procedure: Erector Spinae Plane Block

dexamethasone combined with bupivacaine

EXPERIMENTAL

use of dexamethasone combined with bupivacaine for erector spinae plane block

Procedure: Erector Spinae Plane Block

Interventions

dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries.

dexamethasone combined with bupivacainedexmedetomidine combined with bupivacaine

Eligibility Criteria

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

You may qualify if:

  • Age :18 years old and older. Patients undergoing open abdominal surgery.

You may not qualify if:

  • Patient refusal
  • known sensitivity or contraindication to any of study drugs
  • contraindications for local anesthesia
  • Patients with local infection at site of puncture
  • uncooperative patients
  • history of psychological disorders or chronic pain and significant liver or renal disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

    PMID: 20418538BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

loay GAMAL loay Gamal, master

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
LGamal

Study Record Dates

First Submitted

October 24, 2024

First Posted

October 26, 2024

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

October 26, 2024

Record last verified: 2024-10