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

Primary Purpose

Chronic Pain, Acute Pain, Cotinine, Hysterectomy

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
measuring cotinine level
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Chronic Pain, Acute Pain, Cotinine, Hysterectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mustafa Kemal University Medicine Faculty Anesthesiology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

low (less 10ng/dl)

medium (10-500ng/dl)

high (more 500ng/dl)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Chronic pain: VAS score
3rd month pain after hysterectomy (VAS score)

Secondary Outcome Measures

Acute pain: VAS score
Postoperative 24 hrs after hysterectomy (VAS score)

Full Information

First Posted
February 14, 2020
Last Updated
February 17, 2020
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT04274673
Brief Title
The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy
Official Title
The Correlation Between the Cotinine Levels in Urine and Postoperative Acute and Chronic Pain in Open Abdominal Hysterectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
May 13, 2020 (Anticipated)
Study Completion Date
May 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Acute Pain, Cotinine, Hysterectomy

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
low (less 10ng/dl)
Arm Type
Other
Arm Description
Patients who have low cotinine levels (less 10ng/dl)
Arm Title
medium (10-500ng/dl)
Arm Type
Other
Arm Description
Patients who have medium cotinine levels (less 10-500ng/dl)
Arm Title
high (more 500ng/dl)
Arm Type
Other
Arm Description
Patients who have high cotinine levels (less 10-500ng/dl)
Intervention Type
Device
Intervention Name(s)
measuring cotinine level
Intervention Description
Measuring of the cotinine levels
Primary Outcome Measure Information:
Title
Chronic pain: VAS score
Description
3rd month pain after hysterectomy (VAS score)
Time Frame
Postoperative 3 months
Secondary Outcome Measure Information:
Title
Acute pain: VAS score
Description
Postoperative 24 hrs after hysterectomy (VAS score)
Time Frame
Postoperative 48 hours

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Onur Koyuncu
Phone
+905337744757
Email
onurko@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sumeyra Gokdemir
Phone
+905073992192
Email
sumeyray86@gmail.com
Facility Information:
Facility Name
Mustafa Kemal University Medicine Faculty Anesthesiology Department
City
Hatay
ZIP/Postal Code
31000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Onur Koyuncu, Assist. Prof
Phone
5337744757
Email
onurko@yahoo.com
First Name & Middle Initial & Last Name & Degree
Onur Koyuncu, Assoc.Prof
First Name & Middle Initial & Last Name & Degree
Sumeyra Yesil, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
28472423
Citation
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.
Results Reference
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The Correlation Between Cotinine and Postoperative Acute and Chronic Pain After Hysterectomy

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