NCT03150732

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started Aug 2022

Typical duration 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

First Submitted

Initial submission to the registry

May 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
5.2 years until next milestone

Study Start

First participant enrolled

August 10, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

1.5 years

First QC Date

May 8, 2017

Last Update Submit

February 18, 2024

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Duration of postoperative Analgesia

    minutes

    Postoperative 24 hours

Secondary Outcomes (3)

  • Diclofenac analgesic consumption

    Postoperative 24 hours

  • Cortisol level

    Preoperative and at 4 hours after skin incision

  • Severity of postoperative Pain

    Postoperative 24 hours

Study Arms (2)

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

Systemic nalbuphineDRUG

Patients will receive systemic nalbuphine 10 mg

Systemic nalbuphine group
Local nalbuphineDRUG

Patients will receive local nalbuphine 10 mg

Local nalbuphine group

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for elective unilateral hand surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed H Bakri

Asyut, 71526, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

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
Model Details: Two groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of anesthesia & ICU

Study Record Dates

First Submitted

May 8, 2017

First Posted

May 12, 2017

Study Start

August 10, 2022

Primary Completion

February 10, 2024

Study Completion

February 10, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)