NCT02017314

Brief Summary

The aim of the study is to observe if any correlation between Body mass index and VAS values exists in patients who has gone under abdominal surgery. Group I : Patients with BMI\<30 Group II: Patients with BMI between 30 and 34.9 Group III: Patients with BMI between 35 and 39.9 Group IV: Patients with BMI between 40 and 49.9 Group V : Patients with BMI \>50 After the end of surgery patients will be extubated and in the recovery room morphine PCA (patient-controlled analgesia) treatment will be started according to their adjusted body weight. When VAS values over 4,10 mg/kg Paracetamol IV will be used as an escape treatment. VAS values and Delivery and Demand of the PCA and additional need for analgesics will be recorded in the first 48 hours.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

4 months

First QC Date

December 8, 2013

Last Update Submit

December 16, 2013

Conditions

Keywords

morbid obesitypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Pain Scores on the Visual Analog Scale

    Correlation between the VAS Scores and BMI will evaluated

    48 hours

Study Arms (5)

Group 5

ACTIVE COMPARATOR

Patients with BMI \> 50

Drug: Morphine

Group IV

ACTIVE COMPARATOR

Patients with BMI between 40 and 49.9

Drug: Morphine

Group III

ACTIVE COMPARATOR

Patients with BMI between 35 and 39.9

Drug: Morphine

Group II

ACTIVE COMPARATOR

patients with BMI between 30 and 34.9

Drug: Morphine

Group I

ACTIVE COMPARATOR

Patients with BMI \<30

Drug: Morphine

Interventions

Group 5Group IGroup IIGroup IIIGroup IV

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients undergoing abdominal surgery and who will be given PCA treatment for postoperative pain.

You may not qualify if:

  • patients younger than 18 years old, patients with uncompensated diabetes or related polyneuropathy, patients receiving antidepressants or have a diagnosis of depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cerrahpasa Medical School

Istanbul, Marmara, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Choi YK, Brolin RE, Wagner BK, Chou S, Etesham S, Pollak P. Efficacy and safety of patient-controlled analgesia for morbidly obese patients following gastric bypass surgery. Obes Surg. 2000 Apr;10(2):154-9. doi: 10.1381/096089200321668703.

    PMID: 10782177BACKGROUND

MeSH Terms

Conditions

Obesity, MorbidPain, Postoperative

Interventions

Morphine

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPainNeurologic Manifestations

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

guniz koksal, Ass.Prof

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assc.Prof

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 20, 2013

Study Start

November 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations