Intraoperative Intravenous Lidocaine

Pain Intensity Clinical Trial

Official title:

Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00965796
• Other study ID #: IO-Lido
• Status: Completed
• Phase: N/A
• First received: August 24, 2009
• Last updated: August 25, 2009
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: August 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.

Description:

Study design A prospective, randomized, double-blind study was conducted according to ethical guidelines for research involving humans. The study was approved by the Ethics Committee of the institution and all patients signed a free informed consent form. The patients were randomly allocated to two groups consisting of the same number of subjects by drawing lots.

One physician prepared the solutions and handed them over to the anesthetist who was unaware of the content of the solutions. The volume of the solutions was the same. The researcher was unaware to which group the patient belonged until the end of the study.

Exclusion criteria Excluded from the study were patients with cardiac arrhythmia; myocardiopathy; altered cardiac conduction; psychiatric, hepatic or respiratory disease; and patients receiving any type of analgesic during the week before surgery.

Patients Forty women (ASA 1 or 2) aged 18 to 60 years undergoing hysterectomy were studied.

Treatment Patients of group 1 (n = 20) received lidocaine (2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure.

Anesthesia Oral midazolam (15 mg) was administered one hour before anesthesia as pre-anesthetic medication. Anesthesia was induced with 5 µg/kg fentanyl and 2 mg/kg propofol. Neuromuscular block was maintained with atracurium. Anesthesia was maintained with O2/isoflurane.

Patient assessment The supplemental morphine doses necessary during the first 24 h and the time to first analgesic request were recorded. Pain intensity was evaluated at rest on a numerical scale ranging from 0 to 10 (0 = no pain and 10 = most intense pain possible) at the following times: T0 (immediately after arousal), and 6, 12, 18 and 24 h after arousal. Side effects were recorded.

Statistical analysis The results were analyzed statistically with the Instat Graph program using parametric and nonparametric tests, depending on the nature of the variables studied. Measures of central tendency (means) and dispersion (standard deviation) were used. The level of significance was set at < 0.05. The following tests were used: Mann-Whitney test for age, body mass index, duration of anesthesia and surgery, time to first analgesic supplementation, total amount of morphine, pain intensity, and isoflurane consumed; Student t-test for weight and height; and Friedman test for pain intensity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA 1 or 2, aged 18 to 60 years undergoing hysterectomy

Exclusion Criteria:

• Cardiac arrhythmia; myocardiopathy

• Altered cardiac conduction

• Psychiatric, hepatic or respiratory disease

• Patients receiving any type of analgesic during the week before surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain Intensity

Intervention

Drug:
• Lidocaine
Lidocaine 2 mg/kg/h- during surgical procedure Saline

Locations

Country	Name	City	State
Brazil	Rioko K Sakata- Universidade Federal de São Paulo	São Paulo	Rua Botucatu-593
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain		24hours	No