NCT02924974

Brief Summary

This study will investigate if a single shot of spinal morphine will increase patient satisfaction when compared to intravenous morphine in Robot-Assisted Radical Prostatectomy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2016

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

September 1, 2016

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2018

Completed
Last Updated

August 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.7 years

First QC Date

September 29, 2016

Last Update Submit

August 6, 2018

Conditions

MorphineInjections, SpinalProstatectomyPatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction

    Quality of Recovery-15 questionnaire

    day 1

Study Arms (2)

Control

SHAM COMPARATOR

subcutaneous lidocaïne and intravenous loading dose of morphine

Drug: Lidocaine

Intervention

EXPERIMENTAL

Spinal injection of 4 or 5 ml of bupivacaine/morphine 2,5 mg/ml/60mcg/ml. The reduction to 4 ml is for patients over 75 years of age

Drug: Morphine

Interventions

MorphineDRUG

mixed with bupivacaine

Intervention
LidocaineDRUG

sham procedure (s.c. lidocaïne)

Control

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for Robot-Assisted Radical Prostatectomy

You may not qualify if:

  • Contra-indications to spinal anesthesia (severe aortic stenosis, coagulation disorders)
  • Contra-indications to study medication (local anesthetics, morphine, paracetamol, metamizol)
  • Conversion to an open procedure
  • Post-operative ICU-admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maasstad Hospital

Rotterdam, Netherlands

Location

Related Publications (1)

  • Koning MV, de Vlieger R, Teunissen AJW, Gan M, Ruijgrok EJ, de Graaff JC, Koopman JSHA, Stolker RJ. The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial. Anaesthesia. 2020 May;75(5):599-608. doi: 10.1111/anae.14922. Epub 2019 Dec 17.

    PMID: 31845316DERIVED

MeSH Terms

Conditions

Patient Satisfaction

Interventions

MorphineLidocaine

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seppe Koopman, MD, PhD

    Maasstad Ziekenhuis

    STUDY CHAIR

  • Aart Jan W Teunissen, MD

    Maasstad Ziekenhuis

    STUDY CHAIR

  • Mark V Koning, MD, DESA

    Maasstad Ziekenhuis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 5, 2016

Study Start

September 1, 2016

Primary Completion

May 25, 2018

Study Completion

August 6, 2018

Last Updated

August 7, 2018

Record last verified: 2018-03

Locations

NL(1)