Systemic Nalbuphine Versus Intravenous Regional Anesthesia | NCT03150732

Studies
Systemic Nalbuphine Versus Intravenous Regional Anesthesia

NCT03150732

Sponsor

Assiut University

Status

Completed

Last Update Posted

Feb 20, 2024Actual

Enrollment

82Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Systemic nalbuphine
Local nalbuphine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 10, 2022Actual

Primary Completion Date

Feb 10, 2024Actual

Completion Date

Feb 10, 2024Actual

First Submitted Date

May 8, 2017

First Submission Date that Met QC Criteria

May 10, 2017

First Posted Date

May 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2024

Last Update Posted Date

Feb 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

82Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Systemic nalbuphine group	Active Comparator	53 patients will receive nalbuphine systemically	Drug: Systemic nalbuphine
Local nalbuphine group	Active Comparator	53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)	Drug: Local nalbuphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Systemic nalbuphine	Drug	Patients will receive systemic nalbuphine 10 mg	Systemic nalbuphine group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of postoperative Analgesia	minutes	Postoperative 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Diclofenac analgesic consumption	mg	Postoperative 24 hours
Cortisol level	Level of cortisone in blood (nmol/L)	Preoperative and at 4 hours after skin incision

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mohamed H Bakri		Asyut		71526	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided