NCT01707251

Brief Summary

Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery. Secondary objective is to determine if it decreases respiratory depression measured using RD, improves area under curve (AUC) for pain scores at rest (AUCr) and with cough (AUCa) and pressure pain threshold (PPT) (important for mobilization). Tertiary objective is to compare incidence of nausea/vomiting, sedation, itching, blood transfusion, over sedation, urinary retention, GI or surgical bleeding, renal dysfunction, time to clears and baseline activity in ibuprofen and control groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 obesity

Timeline
Completed

Started Oct 2012

Typical duration for phase_4 obesity

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, 2012

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 16, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 3, 2015

Status Verified

September 1, 2015

Enrollment Period

2.4 years

First QC Date

October 10, 2012

Last Update Submit

September 2, 2015

Conditions

Obesity

Keywords

Obesity, MorbidBariatric SurgeryLaparoscopyIntravenous IbuprofenAnalgesiaMorphine

Outcome Measures

Primary Outcomes (1)

  • 24 hours postoperative morphine requirement using IV PCA

    Will test if IV ibuprofen decrease postoperative morphine requirement.

    24 hours

Secondary Outcomes (3)

  • Respiratory depression

    24 hours postoperative

  • Pain scores

    24 hours postoperatively

  • Pressure pain thresholds

    24 hours

Other Outcomes (23)

  • Nausea/vomiting

    24 hours

  • Transfusion requirement

    3 days

  • Urinary retention

    3 days

  • +20 more other outcomes

Study Arms (2)

Intravenous Ibuprofen

EXPERIMENTAL

800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).

Drug: Intravenous Ibuprofen

Saline

PLACEBO COMPARATOR

IV saline every 6 hours starting preoperatively (5 doses).

Drug: Saline

Interventions

Intravenous IbuprofenDRUG

800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).

Also known as: Caldorol
Intravenous Ibuprofen
SalineDRUG

Placebo control

Saline

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center

You may not qualify if:

  • Patients with history of ibuprofen or aspirin allergy
  • morphine allergy
  • opioid or psychotropic medication use pre-operatively
  • positive preoperative U-tox screening
  • unable to sign consent and patients unable to understand or use patient controlled analgesia (PCA) or report pain intensity
  • GFR \<60 or history of GI bleed within 6 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jacobi Medical Center

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

ObesityObesity, MorbidAgnosia

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Mindaugas Pranevicius, MD

    Jacobi Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Anesthesiologist, Director of Pain Medicine

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 16, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 3, 2015

Record last verified: 2015-09

Locations

US(1)