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

Ain Shams University

Status and phase: Completed; Early Phase 1

Conditions: Pain, Postoperative

Treatments: Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]; Drug: morphine sulphate (10mg/ ml ampoule)

Study type: Interventional

Funder types: Other

Identifiers

NCT05150756

R 35/ 2021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Group Lidocaine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]

Group Morphine

Active Comparator group

Description:

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

Treatment:

Drug: morphine sulphate (10mg/ ml ampoule)