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

NCT ID: NCT04274673

Last Updated: 2020-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

158 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-05-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain, Acute Pain, Cotinine, Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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low (less 10ng/dl)

Patients who have low cotinine levels (less 10ng/dl)

Group Type OTHER

measuring cotinine level

Intervention Type DEVICE

Measuring of the cotinine levels

medium (10-500ng/dl)

Patients who have medium cotinine levels (less 10-500ng/dl)

Group Type OTHER

measuring cotinine level

Intervention Type DEVICE

Measuring of the cotinine levels

high (more 500ng/dl)

Patients who have high cotinine levels (less 10-500ng/dl)

Group Type OTHER

measuring cotinine level

Intervention Type DEVICE

Measuring of the cotinine levels

Interventions

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measuring cotinine level

Measuring of the cotinine levels

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Onur Koyuncu

Assoc.Prof.MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mustafa Kemal University Medicine Faculty Anesthesiology Department

Hatay, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Onur Koyuncu

Role: CONTACT

+905337744757

Sumeyra Gokdemir

Role: CONTACT

+905073992192

Facility Contacts

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Onur Koyuncu, Assist. Prof

Role: primary

5337744757

References

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Montbriand JJ, Weinrib AZ, Azam MA, Ladak SSJ, Shah BR, Jiang J, McRae K, Tamir D, Lyn S, Katznelson R, Clarke HA, Katz J. Smoking, Pain Intensity, and Opioid Consumption 1-3 Months After Major Surgery: A Retrospective Study in a Hospital-Based Transitional Pain Service. Nicotine Tob Res. 2018 Aug 14;20(9):1144-1151. doi: 10.1093/ntr/ntx094.

Reference Type BACKGROUND
PMID: 28472423 (View on PubMed)

Other Identifiers

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2017/181

Identifier Type: -

Identifier Source: org_study_id

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