Clinical trial NCT05150756: Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
Official title: Intraoperative Lidocaine Infusion as a Sole Analgesic Versus Morphine in Laparoscopic Gastric Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pain, Postoperative
Keywords: lidocaine
morphine
analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Post-operative pain score at rest
timeFrame: 1hour
Secondary outcomes:
measure: Duration of surgery
timeFrame: 3 hours
measure: Duration of anesthesia
timeFrame: 4 hours
measure: mean values of mean blood pressure (MBP)
timeFrame: 5 hours
measure: Number of patients requiring intra-operative morphine
timeFrame: 4hours
measure: sPO2
timeFrame: 5 hours
measure: Respiratory rate
timeFrame: 5 hours
measure: Post-operative nausea and/or vomiting
timeFrame: 1 hour
measure: Post-operative sedation score
timeFrame: 1 hour
measure: Modified Aldrete Score
timeFrame: 1 hour
measure: mean values of heart rate (HR)
timeFrame: 5 hours
measure: Number of patients requiring postoperative additional morphine doses
timeFrame: 1 hour
measure: the total dose of morphine given to each patient
timeFrame: 5 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References: