Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery

Postoperative opioid-centric pain management strategies in obese patients are accompanied by the possible development of; opioid-induced ventilatory impairment (OIVI) and hypoxemia. This presents as sedation and respiratory depression, combined with upper airway obstruction and hypercapnia. If it remains undetected and untreated, it can result in increased perioperative morbidity and mortality.Thus, an increased interest in the use of non-opioid analgesic adjuncts has been prompted.

Intra-operative intravenous lidocaine infusion has analgesic, anti-inflammatory, anti-hyperalgesic, opioid-sparing effects with an enhanced recovery after surgery (ERAS) profile. Its postoperative analgesia may last after reduction of its plasma concentration. So, lidocaine could be a good alternative in bariatric surgery.

Lidocaine has been studied as part of an opioid-free multimodal analgesia in morbidly obese patients. Also, its use in bariatric surgery showed a decrease in postoperative opioid use and improvement in the quality of recovery.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]; Drug: morphine sulphate (10mg/ ml ampoule)

Detailed Description

compare the postoperative analgesic effect of intraoperative lidocaine infusion (Study group) used as a sole analgesic agent, to the intraoperative intravenous morphine (Control group) in laparoscopic gastric bypass surgery.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I- II
• body mass index (BMI) ˃ 35
• scheduled to undergo laparoscopic gastric bypass

Exclusion Criteria:

• Patients' refusal
• hypersensitivity to the study medications
• patients with known history of; hepatic disease, renal dysfunction
• severe renal impairment (eGFR <30ml/min/1.73m2)
• heart failure; left ventricular ejection fraction than 35%
• any cardiac dysrhythmias; Adam-Stokes syndrome; Wolff- Parkinson-White syndrome, atrio-ventricular block with heart rate below 50 bpm
• chronic pain
• concomitantly taking beta blocking drugs •substance abuse disorder
• chronic opioid use.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Lidocaine; At induction of anesthesia, patients will receive a loading dose of intravenous (IV) 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% via infusion pump. The infusion will be continued till the end of surgery.	Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]; At induction of anesthesia, patients will receive a loading dose of 1.5mg/kg lidocaine hydrochloride 2% slowly over 3 min followed by IV infusion of 2mg/kg/hr lidocaine hydrochloride 2% till the end of surgery; Other Names: Xylocaine 2%
Active Comparator: Group Morphine; At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery	Drug: morphine sulphate (10mg/ ml ampoule); At induction of anesthesia, patients will receive a loading dose of IV 0.1mg/kg morphine sulphate slowly over 3 minutes followed by IV infusion of normal saline via infusion pump. The infusion will be continued till the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain score at rest	Intensity of pain will be monitored ; on arrival to the PACU, at 20, 40 and 60 minutes after arrival to the PACU by the Numeric Pain Rating Scale. The Numeric Pain Rating Scale (NPRS) is a segmented numeric version of the visual analog scale (VAS) in which the patient selects a whole number (0-10 integers) that best reflects the intensity of pain felt.Where 0 is no pain felt and 10 is the worst pain.	1hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	measured in minutes	3 hours
Duration of anesthesia	measured in minutes	4 hours
mean values of mean blood pressure (MBP)	mean values of MBP will be recorded as base line value, before induction of anesthesia, 5 minutes after endotracheal intubation, before pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU	5 hours
Number of patients requiring intra-operative morphine	Number of patients requiring intra-operative morphine will be recorded	4hours
sPO2	recorded in the induction room and in the PACU.	5 hours
Respiratory rate	recorded in the induction room and in the PACU	5 hours
Post-operative nausea and/or vomiting	number of patients will be recorded	1 hour
Post-operative sedation score	From 0 to 4	1 hour
Modified Aldrete Score	score from 0 to 10. Higher score means patient is fit to transfer to the ward. In the PACU, patients with score ≥ 9 will be transferred to the surgical unit	1 hour
mean values of heart rate (HR)	mean values of HR will be recorded as base line value, before induction of anesthesia, 5 minutes after endotracheal intubation, before pneumoperitoneum, after release of pneumoperitoneum and 10 min after extubation in the PACU	5 hours
Number of patients requiring postoperative additional morphine doses	Number of patients requiring postoperative additional morphine doses willbe recorded	1 hour
the total dose of morphine given to each patient	the total dose of morphine given to each patient will be recorded in milligrams	5 hours

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): September 20, 2022

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: lidocaine; morphine; analgesia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Morphine
• Other Study ID Numbers: R 35/ 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No