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Not yet recruitingNCT07865455Updated Oct 8, 2026

Effect of Labetalol, Magnesium Sulfate, or Lidocaine on Opioid Consumption During Laparoscopic Cholecystectomy

A Phase 4 interventional study of Labetalol and Magnesium Sulfate in Postoperative Pain and Cholelithiasis, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Assiut University · Phase 4, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Laparoscopic cholecystectomy (gallbladder removal) is one of the most common abdominal operations performed worldwide. Despite its minimally invasive approach, up to half of patients experience notable postoperative pain, which often requires opioid painkillers. Reducing perioperative opioid consumption through non-opioid medications helps minimize opioid-related side effects, improve comfort, and enhance postoperative recovery.

The primary purpose of this clinical trial is to compare the pain-relieving and opioid-sparing effects of three intravenous medications (labetalol, magnesium sulfate, and lidocaine) administered during elective laparoscopic cholecystectomy under general anesthesia.

Adult participants aged 18 to 60 years will be randomly assigned to one of three parallel groups:

  • Group Lb: Receives intravenous labetalol as an initial loading infusion before induction followed by a continuous infusion during surgery.
  • Group M: Receives intravenous magnesium sulfate as an initial loading infusion before induction followed by a continuous infusion during surgery.
  • Group L: Receives intravenous lidocaine as an initial loading infusion before induction followed by a continuous infusion during surgery.

The main outcome measured is total perioperative opioid consumption during surgery and throughout the first 24 postoperative hours. Investigators will also assess hemodynamic parameters (heart rate and blood pressure), blood oxygen levels, postoperative pain intensity scores, surgeon satisfaction, and the occurrence of any adverse effects.

02

Conditions studied

  • Postoperative Pain
  • Cholelithiasis

Keywords

  • Laparoscopic Cholecystectomy
  • Labetalol
  • Magnesium Sulfate
  • Lidocaine Infusion
  • Opioid-Sparing Analgesia
  • Multimodal Analgesia
  • Opioid Consumption
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Assiut University is the lead sponsor of 4,916 studies on the registry; 2,113 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients scheduled for elective laparoscopic cholecystectomy under general anesthesia.
  • Age between 18 and 60 years.
  • Both male and female patients.
  • American Society of Anesthesiologists (ASA) physical status class I or II.
  • Body mass index (BMI) ≤ 35 kg/m².
  • Patient is cooperative and able to understand study procedures and communicate pain scores using the Visual Analog Scale (VAS).

Exclusion criteria

Exclusion Criteria:

  • Patient refusal to provide signed informed consent.
  • Known allergy, hypersensitivity, or contraindication to lidocaine, labetalol, or magnesium sulfate.
  • Bronchial asthma or severe obstructive airway disease.
  • Second- or third-degree atrioventricular (AV) block, severe bradycardia, or uncontrolled heart failure.
  • Significant hepatic, renal, or cardiac dysfunction.
  • Pre-existing chronic pain requiring regular analgesic therapy, chronic opioid use, or history of substance abuse/opioid dependence.
  • Neurological or psychiatric disorders that may interfere with postoperative pain assessment.
  • Conversion from laparoscopic to open cholecystectomy or performing concomitant surgical procedures.
  • Emergency surgery.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Group Lb: Labetalol Infusion

    Participants receive an initial loading dose of labetalol (0.25 mg/kg) diluted in 100 mL normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous intravenous infusion of 0.5-1 mg/kg/h until the end of the surgical procedure.

    Drug: Labetalol

  • Active comparator
    Group M: Magnesium Sulfate Infusion

    Participants receive an initial loading dose of magnesium sulfate (50 mg/kg) diluted in 100 mL normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous intravenous infusion of 25 mg/kg/h until the end of the surgical procedure.

    Drug: Magnesium Sulfate

  • Active comparator
    Group L: Lidocaine Infusion

    Participants receive an initial loading dose of lidocaine (1.5-2 mg/kg) diluted in 100 mL normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous intravenous infusion of 2 mg/kg/h until the end of the surgical procedure.

    Drug: Lidocaine

Interventions

  • DrugLabetalol

    Administered intravenously with an initial loading dose of 0.25 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 0.5-1.0 mg/kg/h until completion of the surgical procedure.

  • DrugMagnesium Sulfate

    Administered intravenously with an initial loading dose of 50 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 25 mg/kg/h until completion of the surgical procedure.

  • DrugLidocaine

    Administered intravenously with an initial loading dose of 1.5-2.0 mg/kg diluted in 100 mL of 0.9% normal saline infused over 15 minutes prior to induction of general anesthesia, followed by a continuous maintenance infusion of 2.0 mg/kg/h until completion of the surgical procedure.

06

What researchers measure

Primary outcomes

  1. Total 24-Hour Opioid Consumption

    Cumulative amount of intraoperative and postoperative rescue opioids administered, converted to intravenous morphine milligram equivalents (mg).

    Time frame: 24 hours postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07865455
Lead sponsor
Assiut University
Responsible party
Ziad Mohamed Mostafa Al-Qousi (Resident, Assiut University) — Principal investigator
First posted
Oct 8, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 8, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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