Evaluation of the Effect of Venous Diameter Measurement by Ultrasonography on Pain and Withdrawal Response

Completed

• Conditions: Pain; Withdrawal
• Interventions: Diagnostic Test: Pain Score; Diagnostic Test: Withdrawal movement score; Diagnostic Test: hemodynamic response

• Registration Number: NCT03376308
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

During general anesthesia, intravenous (IV) medications can disrupt the patient's comfort by causing a pain sensation or a withdrawal response in the heart. Propofol and rocuronium are among the most common causes of this condition.

In recent years, the use of ultrasonography (USG) in anesthesia has become widespread with the rapid advancement of technology. The use of the patient's head is a non invasive method.

This study is aimed to evaluate whether the size of the venous diameter assessed by ultrasonography in our study is an effect on pain and withdrawal response after drug injections.

Detailed Description

The study was conducted in patients who underwent surgical procedures under general anesthesia by obtaining consent from the Adnan Menderes University Medical Faculty Ethics Board and written consent from the patients and then being admitted to the ASA I-II age group 18-70 years of age.

Patients with peripheric vascular disease, vasculitis, rheumatologic disease, non-cooperative, under the age of 18 and over 70, ASA III and above, allergic to general anesthetic agents and refusing to participate in the study were excluded from the study.

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2017-10-01
• Study Completion: 2017-10-01
• Status Verified: 2017-11
• Study First Submitted: 2017-12-13
• Study First Submitted QC: 2017-12-13
• Last Update Submitted: 2017-12-16
• Study First Posted: 2017-12-18
• Last Update Posted: 2017-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

18- 70 years of ASA (American society of anesthesiology) physical status I- II who were to undergo various elective operations

Exclusion Criteria

Rheumatologic disease Peripheric vascular disease Vasculitis Patients with chronic pain syndrome, Patients with neurologic deficits, Patients with thrombophlebitis, Patients with difficult venous access, Patients with allergy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Withdrawal movement score	Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.
Group 1	hemodynamic response	Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.
Group 1	Pain Score	Venous diameter measurements were made via the USG in the hand dorsum. Transverse venous diameter ≤2mm was defined group 1. Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.
Group 2	Pain Score	Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter \>2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.
Group 2	Withdrawal movement score	Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter \>2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.
Group 2	hemodynamic response	Venous diameter measurements were made via the USG in the hand dorsum.Transverse venous diameter \>2mm was defined group 2.Anesthesia induction drugs were all treated in the same order and dose. Pain score, withdrawal movement score and hemodynamic response was recorded.

Primary Outcome Measures

Name	Time	Method
The injection pain due to propofol	6 month	Pain will be recorded and graded using a 4-point scale (none, mild, moderate, or severe).

Secondary Outcome Measures

Name	Time	Method
The withdrawal movement due to rocuronium	6 month	Withdrawal movements are scored as follows: (a) no movement response, (b) movement limited to the wrist, (c)movement limited to the elbow/shoulder, or (d) generalized movement response.

Trial Locations

Locations (1)

Adnan Menderes University Training and Research Hospital; 🇹🇷 Aydın, Turkey