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

Phase 4

• Conditions: Chronic Pain, Acute Pain, Cotinine, Hysterectomy
• Interventions: Device: measuring cotinine level

• Registration Number: NCT04274673
• Lead Sponsor: Mustafa Kemal University

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.

Study Timeline

• Study Start: 2019-12-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-17
• Last Update Submitted: 2020-02-17
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Primary Completion: 2020-05-13
• Study Completion: 2020-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low (less 10ng/dl)	measuring cotinine level	Patients who have low cotinine levels (less 10ng/dl)
medium (10-500ng/dl)	measuring cotinine level	Patients who have medium cotinine levels (less 10-500ng/dl)
high (more 500ng/dl)	measuring cotinine level	Patients who have high cotinine levels (less 10-500ng/dl)

Primary Outcome Measures

Name	Time	Method
Chronic pain: VAS score	Postoperative 3 months	3rd month pain after hysterectomy (VAS score)

Secondary Outcome Measures

Name	Time	Method
Acute pain: VAS score	Postoperative 48 hours	Postoperative 24 hrs after hysterectomy (VAS score)

Trial Locations

Locations (1)

Mustafa Kemal University Medicine Faculty Anesthesiology Department; 🇹🇷 Hatay, Turkey