NCT02678585

Brief Summary

The effect of addition of nalbuphine to lidocaine in intravenous regional anesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

December 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 10, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

3 months

First QC Date

February 4, 2016

Last Update Submit

June 23, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Tourniquet and postoperative pain measured by visual analogue scale

    4 hours

Secondary Outcomes (1)

  • Cortisol level

    4 hours

Study Arms (2)

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

LidocaineDRUG

53 patients received intravenous regional lidocaine

Control group
NalbuphineDRUG

53 patients received intravenous regional lidocaine plus nalbuphine

Nalbuphine

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

NalbuphineLidocaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 4, 2016

First Posted

February 10, 2016

Study Start

December 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 26, 2018

Record last verified: 2018-06

Locations

EG(1)