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

Chronic Pain, Acute Pain, Cotinine, Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274673
• Other study ID #: 2017/181
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: February 2020
• Source: Mustafa Kemal University
• Contact: Onur Koyuncu
• Phone: +905337744757
• Email: onurko[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: May 15, 2020
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Chronic Pain, Acute Pain, Cotinine, Hysterectomy

Intervention

Device:
• measuring cotinine level
Measuring of the cotinine levels

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University Medicine Faculty Anesthesiology Department	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic pain: VAS score	3rd month pain after hysterectomy (VAS score)	Postoperative 3 months
Secondary	Acute pain: VAS score	Postoperative 24 hrs after hysterectomy (VAS score)	Postoperative 48 hours