NCT00720343

Brief Summary

This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_4 postoperative-pain

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

First Submitted

Initial submission to the registry

July 21, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 22, 2008

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

March 25, 2016

Completed
Last Updated

July 9, 2024

Status Verified

June 1, 2024

Enrollment Period

2.3 years

First QC Date

July 21, 2008

Results QC Date

March 23, 2016

Last Update Submit

June 12, 2024

Conditions

Postoperative PainInflammation

Outcome Measures

Primary Outcomes (1)

  • Numerical Rating Scale (NRS) Pain Score

    NRS range is 0-10 where 0 is no pain and 10 is the worst pain imaginable

    End of surgery, and 1 hour after surgery

Secondary Outcomes (1)

  • Amount of Morphine Used by Participants Post-surgery

    1 hour after surgery, and 24 hours after surgery

Study Arms (2)

Choline

EXPERIMENTAL

Oral choline

Drug: Choline

Placebo

PLACEBO COMPARATOR

Gelatin Capsule

Drug: Placebo

Interventions

CholineDRUG

Oral Choline 20 grams before surgery

Also known as: Tricholine 1200
Choline
PlaceboDRUG

Gelatin Capsule

Also known as: Gelatin Capsule
Placebo

Eligibility Criteria

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

You may qualify if:

  • open pelvic surgery
  • able to swallow pills

You may not qualify if:

  • chronic pain
  • opioid use
  • pregnancy
  • lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Related Publications (1)

  • Sidhu N, Davies S, Nadarajah A, Rivera J, Whittington R, Mercier RJ, Virag L, Wang S, Flood P. Oral choline supplementation for postoperative pain. Br J Anaesth. 2013 Aug;111(2):249-55. doi: 10.1093/bja/aet031. Epub 2013 Apr 7.

    PMID: 23568851RESULT

MeSH Terms

Conditions

Pain, PostoperativeInflammation

Interventions

CholineGelatin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesTrimethyl Ammonium CompoundsQuaternary Ammonium CompoundsOnium CompoundsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Pamela Flood, M.D.
Organization
Stanford University
pflood@stanford.edu
201-370-3933

Study Officials

  • Pamela Flood, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
SPONSOR

Study Record Dates

First Submitted

July 21, 2008

First Posted

July 22, 2008

Study Start

February 1, 2009

Primary Completion

June 1, 2011

Study Completion

December 1, 2012

Last Updated

July 9, 2024

Results First Posted

March 25, 2016

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)