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

NCT05150756 | Completed Early Phase 1

• 1 other identifier: R 35/ 2021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative

Keywords

lidocaine; morphine; analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Duration of surgery

  3 hours

• Duration of anesthesia

  4 hours

• mean values of mean blood pressure (MBP)

  5 hours

• Number of patients requiring intra-operative morphine

  4hours

• sPO2

  5 hours

Study Arms (2)

Group Lidocaine

ACTIVE COMPARATOR

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]

Group Morphine

ACTIVE COMPARATOR

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)

Interventions

Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE] DRUG

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

Also known as: Xylocaine 2%

Group Lidocaine

morphine sulphate (10mg/ ml ampoule) DRUG

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

Group Morphine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Lidocaine; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesia, Intensive care and Pain Management

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: December 9, 2021
• Study Start: January 1, 2022
• Primary Completion: July 28, 2022
• Study Completion: September 20, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)