NCT00772187

Brief Summary

Main Hypothesis: laparoscopic surgery is very painful to patient during and after surgery. We would like to compare different analgesic methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

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

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
5 months until next milestone

First Posted

Study publicly available on registry

October 15, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 22, 2010

Status Verified

July 1, 2010

Enrollment Period

1.9 years

First QC Date

May 21, 2008

Last Update Submit

September 21, 2010

Conditions

Analgesia

Keywords

Laparoscopic surgery (general surgery).

Outcome Measures

Primary Outcomes (1)

  • Good analgesic method with minimal side effect.

Study Arms (2)

1

EXPERIMENTAL

General anesthesia + I.V pca

Drug: general anesthesia (fentanyl)

2

EXPERIMENTAL

General anesthesia + spinal analgesia + I.V pca

Drug: morphineDrug: intrathecal analgesia (morphine)

Interventions

morphineDRUG

Single dose: 0.1-0.5 mg

2
intrathecal analgesia (morphine)DRUG

0.1-0.5 mg of morphine

2
general anesthesia (fentanyl)DRUG

general anesthesia alone

1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Laparoscopic (general) Surgery
  • Age\>18
  • ASA\<4
  • Morning surgery

You may not qualify if:

  • Patient refusal
  • contra-indication for treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, Israel, 31096, Israel

Location

MeSH Terms

Conditions

Agnosia

Interventions

MorphineAnesthesia, GeneralFentanyl

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsAnesthesiaAnesthesia and AnalgesiaPiperidinesHeterocyclic Compounds, 1-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

October 15, 2008

Study Start

October 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 22, 2010

Record last verified: 2010-07

Locations

IL(1)