Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

NCT ID: NCT03748108

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-08-01

Brief 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.

Detailed 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.

Conditions

Abdominal Hysterectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

lidocaine

A bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.

Group Type: EXPERIMENTAL

lidocaine

Intervention Type: DRUG

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 a saline placebo over 15 s just before the induction of general anesthesia.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.

Interventions

lidocaine

a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.

Intervention Type: DRUG

Placebo

a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.

Intervention Type: DRUG

Other Intervention Names

Experimental; Placebo Comparator

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aswan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

hany farouk

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

hany f sallam, md

Role: PRINCIPAL_INVESTIGATOR

Aswan University Hospital

Locations

Aswan University

Aswān, , Egypt

Countries

Egypt

Other Identifiers

aswu/275/18

Identifier Type: -

Identifier Source: org_study_id