Skip to main content
OpenTrials
Completed

NCT Number: NCT05150756

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ain-Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Xylocaine 2%

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

Primary outcomes

  1. Post-operative pain score at rest

    Time frame: 1hour

    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.

Secondary outcomes

  1. Duration of surgery

    Time frame: 3 hours

    measured in minutes

  2. Duration of anesthesia

    Time frame: 4 hours

    measured in minutes

  3. mean values of mean blood pressure (MBP)

    Time frame: 5 hours

    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

  4. Number of patients requiring intra-operative morphine

    Time frame: 4hours

    Number of patients requiring intra-operative morphine will be recorded

  5. sPO2

    Time frame: 5 hours

    recorded in the induction room and in the PACU.

  6. Respiratory rate

    Time frame: 5 hours

    recorded in the induction room and in the PACU

  7. Post-operative nausea and/or vomiting

    Time frame: 1 hour

    number of patients will be recorded

  8. Post-operative sedation score

    Time frame: 1 hour

    From 0 to 4

  9. Modified Aldrete Score

    Time frame: 1 hour

    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

  10. mean values of heart rate (HR)

    Time frame: 5 hours

    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

  11. Number of patients requiring postoperative additional morphine doses

    Time frame: 1 hour

    Number of patients requiring postoperative additional morphine doses willbe recorded

  12. the total dose of morphine given to each patient

    Time frame: 5 hours

    the total dose of morphine given to each patient will be recorded in milligrams

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2021
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.