NCT05704673

Brief Summary

the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Status
unknown

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

January 20, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

6 months

First QC Date

January 20, 2023

Last Update Submit

May 5, 2023

Conditions

Inguinal Hernia

Keywords

nalbuphinemorphineIVIntrathecal

Outcome Measures

Primary Outcomes (1)

  • Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair

    investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea to 3 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV b. Secondary (subsidiary): postoperative pain and puririts. \[ Time Frame: 24 hours \] c. Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 3).

    1. a. Primary (main): postoperative nausea and vomiting [ Time Frame: 24 hours ] A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea

Study Arms (2)

group (1)

ACTIVE COMPARATOR

who given intrathecal morphine thin IV nalbuphine and asize of 80 patients

Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.

group (2)

PLACEBO COMPARATOR

who given intrathecal morphine onInguinal hernia druing spinal anathesia

Drug: nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.

Interventions

nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.DRUG

investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.

Also known as: nalbuphine, intrathecal morphine
group (1)group (2)

Eligibility Criteria

Age15 Years - 70 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmales
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients of aged 15-70years old
  • males
  • Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia.
  • ASA grade 1,2
  • normal cardiac and renal function

You may not qualify if:

  • Patient refusal
  • Allergy to the studied drugs.
  • Patients with contraindications to spinal anesthesia
  • ASA grade 3,4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ibrahim AS, Aly MG, Thabet ME, Abdelaziz MR. Effect of adding nalbuphine to intrathecal bupivacaine with morphine on postoperative nausea and vomiting and pruritus after elective cesarean delivery: a randomized double blinded study. Minerva Anestesiol. 2019 Mar;85(3):255-262. doi: 10.23736/S0375-9393.18.12751-9. Epub 2018 May 30.

    PMID: 29856176RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Longitudinal StudiesDouble-Blind MethodNalbuphine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cohort StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthEpidemiologic Research DesignResearch DesignMethodsMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Central Study Contacts

Rehab Marzouk, master

CONTACT

01022290058e01022290058@gmail.com

Prof. Fatma Asker, Professor

CONTACT

01005803969F.askar@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
house officer

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 30, 2023

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

June 1, 2024

Last Updated

May 8, 2023

Record last verified: 2023-05