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

Early Phase 1

Completed

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

• Registration Number: NCT05150756
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study First Submitted: 2021-10-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-09
• Study Start: 2022-01-01
• Primary Completion: 2022-07-28
• Study Completion: 2022-09-20
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Morphine	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
Group Lidocaine	Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]	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.

Primary Outcome Measures

Name	Time	Method
Post-operative pain score at rest	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 Outcome Measures

Name	Time	Method
Duration of surgery	3 hours	measured in minutes
mean values of mean blood pressure (MBP)	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
Post-operative nausea and/or vomiting	1 hour	number of patients will be recorded
Post-operative sedation score	1 hour	From 0 to 4
Modified Aldrete Score	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
Duration of anesthesia	4 hours	measured in minutes
sPO2	5 hours	recorded in the induction room and in the PACU.
Respiratory rate	5 hours	recorded in the induction room and in the PACU
mean values of heart rate (HR)	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
Number of patients requiring postoperative additional morphine doses	1 hour	Number of patients requiring postoperative additional morphine doses willbe recorded
the total dose of morphine given to each patient	5 hours	the total dose of morphine given to each patient will be recorded in milligrams
Number of patients requiring intra-operative morphine	4hours	Number of patients requiring intra-operative morphine will be recorded

Trial Locations

Locations (1)

Ain-Shams University; 🇪🇬 Cairo, Egypt