Intraoperative Intravenous Lidocaine
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Purpose
The objective of the present study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain after hysterectomy.
| Condition | Intervention |
|---|---|
|
Pain Intensity |
Drug: Lidocaine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Effect of Intraoperative Intravenous Lidocaine on Pain After Hysterectomy |
- Pain [ Time Frame: 24hours ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | May 2008 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lidocaine, pain intensity and Saline
(2 mg/kg/h) and patients of group 2 (n = 20) received 0.9% saline infusion throughout the surgical procedure
|
Drug: Lidocaine
Lidocaine 2 mg/kg/h- during surgical procedure Saline
Other Name: Intravenous lidocaine
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Brazil | |
| Rioko K Sakata- Universidade Federal de São Paulo | |
| São Paulo, Rua Botucatu-593, Brazil, 04023-062 | |
| Universidade Federal de São Paulo | |
| São Paulo, Brazil, 04023-062 | |
| Principal Investigator: | Rioko K Sakata, PhD | Universidade Federal de São Paulo |
More Information
No publications provided
| Responsible Party: | Rioko K Sakata, Universidade Federal de São Paulo |
| ClinicalTrials.gov Identifier: | NCT00965796 History of Changes |
| Other Study ID Numbers: | IO-Lido |
| Study First Received: | August 24, 2009 |
| Last Updated: | August 25, 2009 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Federal University of São Paulo:
|
Intravenous lidocaine postoperative analgesia |
Additional relevant MeSH terms:
|
Lidocaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions |
Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anti-Arrhythmia Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 18, 2013