Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia | NCT02678585

Studies
Nalbuphine as an Adjuvant to Intravenous Regional Anesthesia

NCT02678585

Sponsor

Assiut University

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

106Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Nalbuphine
Lidocaine

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

Jun 2018

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

Dec 2015

Primary Completion Date

Mar 2016Actual

Completion Date

Mar 2016Actual

First Submitted Date

Feb 4, 2016

First Submission Date that Met QC Criteria

Feb 5, 2016

First Posted Date

Feb 10, 2016Estimated

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

Jun 23, 2018

Last Update Posted Date

Jun 26, 2018Actual

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

106Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nalbuphine	Active Comparator	53 patients received intravenous regional lidocaine plus Nalbuphine	Drug: Nalbuphine
Control group	Other	53 patients received intravenous regional lidocaine	Drug: Lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nalbuphine	Drug	53 patients received intravenous regional lidocaine plus nalbuphine	Nalbuphine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tourniquet and postoperative pain measured by visual analogue scale		4 hours

Secondary Outcomes

Measure	Description	Time Frame
Cortisol level		4 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult patients
American Society of Anesthesiologists (ASA) physical status I-II
age between 20 and 50 years old
scheduled for elective unilateral short hand surgery

Exclusion Criteria:

allergy to study medications
body mass index > 35 kg/m2
patients with sickle cell disease or Reynaud disease
patient refusal

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university hospital		Asyut		71515	Egypt

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

Intervention Browse Module

MeSH Terms

ID	Term
D009266	Nalbuphine
D008012	Lidocaine

Ancestor Terms

ID	Term
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided