Bolus Administration of Intravenous Lidocaine at the Time of Abdominal Hysterectomy

NCT03748108 | Completed DMC

• 1 other identifier: aswu/275/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Hysterectomy

Keywords

lidocaine; Postoperative Pain; hysterectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Visual analog score during rest

  24 hours post operative

• number of patients need Fentanyl consumption

  24 hours post operative

• number of days patients stay in hospital

  4 weeks

Study Arms (2)

lidocaine

EXPERIMENTAL

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

Drug: lidocaine

Placebo

PLACEBO COMPARATOR

A bolus intravenous dose of a saline placebo over 15 s just before the induction of general anesthesia.

Drug: Placebo

Interventions

lidocaine DRUG

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

Also known as: Experimental

lidocaine

Placebo DRUG

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

Also known as: Placebo Comparator

Placebo

Eligibility Criteria

• Age: 35 Years - 60 Years
• Gender Eligibility Details: women undergoing abdominal hysterectomy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be a single-center, randomized double-blind, placebo-controlled, parallel group trial.

Study Record Dates

• First Submitted: November 18, 2018
• First Posted: November 20, 2018
• Study Start: December 1, 2018
• Primary Completion: March 30, 2020
• Study Completion: August 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Locations

EG (1)