Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

Abdominal Hysterectomy Clinical Trial

Official title:

A Randomized Clinical Trial Estimating the Efficacy of Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy to Decrease Postoperative Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03748108
• Other study ID #: aswu/275/18
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 1, 2020

Study information

• Verified date: August 2020
• Source: Aswan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study to evaluate whether a bolus administration of intravenous lidocaine decreases postoperative pain and represents an opioid-minimizing strategy after abdominal hysterectomy compared with placebo.

Description:

Total abdominal hysterectomy (TAH) is the most common gynecological operation worldwide. Some studies noticed about abused of opioids in postoperative care, led to a more adverse effect of opioids, slow recovery, prolong the length of hospitalized stay and consequently increase the unnecessary cost of treatment.

Guidelines have considered using preoperative analgesics for reducing post-operative opioids consumption, including lidocaine infusion. With its anti-inflammatory, anti-hyperalgesia and analgesic properties, intravenous perioperative lidocaine infusion (IVLI) has been used for optimal postoperative care in different surgeries and in various procedures involving hysterectomy.

Therefore, the aim of this study is to assess the efficacy of bolus administration of intravenous lidocaine at the time of abdominal hysterectomy to decrease postoperative pain and reducing morphine requirements, after TAH.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• Women ranging age between 35-60 years a who undergoing elective total abdominal hysterectomy

Exclusion Criteria:

• Participants had known sensitivity to lidocaine

• Participants had difficulty in intubation

• Participants were on chronic pain medication or already on long-term opioids

• Participants smokers

• Participants with disabilities who were unable to communicate pain levels

• refuse to consent

Related Conditions & MeSH terms

• Abdominal Hysterectomy

Intervention

Drug:
• lidocaine
a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
• Placebo
a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.

Locations

Country	Name	City	State
Egypt	Aswan University	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog score during movement	movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain	30 minutes postoperative
Secondary	Visual analog score during rest	ranging from 0 to 10, where 0 no pain and 10	24 hours post operative
Secondary	number of patients need Fentanyl consumption	number of patients need Fentanyl consumption	24 hours post operative
Secondary	number of days patients stay in hospital	calculation of number of days patients stay in hospital	4 weeks