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

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]
morphine sulphate (10mg/ ml ampoule)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring lidocaine, morphine, analgesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group Lidocaine

Group Morphine

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of surgery
measured in minutes
Duration of anesthesia
measured in minutes
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
Number of patients requiring intra-operative morphine
Number of patients requiring intra-operative morphine will be recorded
sPO2
recorded in the induction room and in the PACU.
Respiratory rate
recorded in the induction room and in the PACU
Post-operative nausea and/or vomiting
number of patients will be recorded
Post-operative sedation score
From 0 to 4
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
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
Number of patients requiring postoperative additional morphine doses
Number of patients requiring postoperative additional morphine doses willbe recorded
the total dose of morphine given to each patient
the total dose of morphine given to each patient will be recorded in milligrams

Full Information

First Posted
October 8, 2021
Last Updated
October 24, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05150756
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
July 28, 2022 (Actual)
Study Completion Date
September 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
lidocaine, morphine, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Lidocaine
Arm Type
Active Comparator
Arm 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.
Arm Title
Group Morphine
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride 2% Intravenous Solution [XYLOCAINE]
Other Intervention Name(s)
Xylocaine 2%
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
morphine sulphate (10mg/ ml ampoule)
Intervention 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
Primary Outcome Measure Information:
Title
Post-operative pain score at rest
Description
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.
Time Frame
1hour
Secondary Outcome Measure Information:
Title
Duration of surgery
Description
measured in minutes
Time Frame
3 hours
Title
Duration of anesthesia
Description
measured in minutes
Time Frame
4 hours
Title
mean values of mean blood pressure (MBP)
Description
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
Time Frame
5 hours
Title
Number of patients requiring intra-operative morphine
Description
Number of patients requiring intra-operative morphine will be recorded
Time Frame
4hours
Title
sPO2
Description
recorded in the induction room and in the PACU.
Time Frame
5 hours
Title
Respiratory rate
Description
recorded in the induction room and in the PACU
Time Frame
5 hours
Title
Post-operative nausea and/or vomiting
Description
number of patients will be recorded
Time Frame
1 hour
Title
Post-operative sedation score
Description
From 0 to 4
Time Frame
1 hour
Title
Modified Aldrete Score
Description
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
Time Frame
1 hour
Title
mean values of heart rate (HR)
Description
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
Time Frame
5 hours
Title
Number of patients requiring postoperative additional morphine doses
Description
Number of patients requiring postoperative additional morphine doses willbe recorded
Time Frame
1 hour
Title
the total dose of morphine given to each patient
Description
the total dose of morphine given to each patient will be recorded in milligrams
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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