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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05150756
• Other study ID #: R 35/ 2021
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2022
• Est. completion date: September 20, 2022

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 20, 2022
• Est. primary completion date: July 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]
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
• 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

Locations

Country	Name	City	State
Egypt	Ain-Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

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