The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy

February 17, 2020 updated by: Onur Koyuncu, Mustafa Kemal University

The Correlation Between the Cotinine Levels in Urine and Postoperative Acute and Chronic Pain in Open Abdominal Hysterectomy Patients

It is known that there is an association between smoking and acute/chronic pain. But it is so difficult to assess this relation with asking questions to the patients in the preoperative period. Because of that we want to measure the levels of the cotinine in the urine and later assess the correlation with acute and chronic pain in hysterectomy patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It is well-known that smoking is very common in the public. The chronic pain after hysterectomy is 20-40%. The open abdominal hysterectomy ratio is 75% of all hysterectomy operations in our country. We know that the reasons of postoperative acute and chronic pain is multifactorial. One of them is smoking which affects the postoperative pain. The best way of measuring the level of cotinine is assesing the urine of the patient. We collect the first urine after induction.

In this study, we aimed to investigate the correlation between the levels of urine cotinine and the acute and chronic postoperative pain in hysterectomy patents.

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Hatay, Turkey, 31000
        • Recruiting
        • Mustafa Kemal University Medicine Faculty Anesthesiology Department
        • Contact:
        • Principal Investigator:
          • Onur Koyuncu, Assoc.Prof
        • Sub-Investigator:
          • Sumeyra Yesil, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA I-II
  • Open abdominal hysterectomy patients

Exclusion Criteria:

  • Chronic pain
  • Chronic pain killer users
  • Axis I psychiatric disease
  • Liver disease
  • Renal disease
  • Drug allergy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: low (less 10ng/dl)
Patients who have low cotinine levels (less 10ng/dl)
Device: measuring cotinine level
Measuring of the cotinine levels
Other: medium (10-500ng/dl)
Patients who have medium cotinine levels (less 10-500ng/dl)
Device: measuring cotinine level
Measuring of the cotinine levels
Other: high (more 500ng/dl)
Patients who have high cotinine levels (less 10-500ng/dl)
Device: measuring cotinine level
Measuring of the cotinine levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain: VAS score
Time Frame: Postoperative 3 months
3rd month pain after hysterectomy (VAS score)
Postoperative 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute pain: VAS score
Time Frame: Postoperative 48 hours
Postoperative 24 hrs after hysterectomy (VAS score)
Postoperative 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Anticipated)

May 13, 2020

Study Completion (Anticipated)

May 15, 2020

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 18, 2020

Study Record Updates

Last Update Posted (Actual)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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