Systemic Nalbuphine Versus Intravenous Regional Anesthesia

NCT ID: NCT03150732

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2024-02-10

Brief Summary

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Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Systemic nalbuphine group

53 patients will receive nalbuphine systemically

Group Type ACTIVE_COMPARATOR

Systemic nalbuphine

Intervention Type DRUG

Patients will receive systemic nalbuphine 10 mg

Local nalbuphine group

53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)

Group Type ACTIVE_COMPARATOR

Local nalbuphine

Intervention Type DRUG

Patients will receive local nalbuphine 10 mg

Interventions

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Systemic nalbuphine

Patients will receive systemic nalbuphine 10 mg

Intervention Type DRUG

Local nalbuphine

Patients will receive local nalbuphine 10 mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for elective unilateral hand surgery.

Exclusion Criteria

* Patient refusal.
* Allergy to study medications
* Body mass index \> 35 kg/ m2
* Patients with sickle cell or Reynaud diseases
* Patients with a history of psychiatric illness or on chronic opioids
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Bakri

Professor of anesthesia & ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mohamed H Bakri

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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000087273

Identifier Type: -

Identifier Source: org_study_id

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