Postoperative PainPhase 4NCT07865455
Effect of Labetalol, Magnesium Sulfate, or Lidocaine on Opioid Consumption During Laparoscopic Cholecystectomy
A Phase 4 study testing Labetalol, Magnesium Sulfate and Lidocaine in people with Postoperative Pain and Cholelithiasis, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain, Cholelithiasis
- What is being tested?
- Labetalol, Magnesium Sulfate and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- Neurological or psychiatric disorders that may interfere with postoperative pain assessment.
- Conversion from laparoscopic to open cholecystectomy or performing concomitant surgical procedures.
- Emergency surgery.
About this study
Official title: Effect of Using Labetalol, Magnesium Sulfate or Lidocaine Infusion on Opioid Consumption During Laparoscopic Cholecystectomy
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.
Read more
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.
- Conditions
- Postoperative Pain, Cholelithiasis
- Being tested
- Labetalol, Magnesium Sulfate, Lidocaine
- Keywords
- Laparoscopic Cholecystectomy, Labetalol, Magnesium Sulfate, Lidocaine Infusion, Opioid-Sparing Analgesia, Multimodal Analgesia, Opioid Consumption
- Medical subject headings
- Pain, Postoperative, Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LabetalolDrug
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.
Magnesium SulfateDrug
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.
LidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Lb: Labetalol Infusion | Experimental | 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. Receives: Drug: Labetalol |
| Group M: Magnesium Sulfate Infusion | Active comparator | 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. Receives: Drug: Magnesium Sulfate |
| Group L: Lidocaine Infusion | Active comparator | 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24-Hour Opioid Consumption
Cumulative amount of intraoperative and postoperative rescue opioids administered, converted to intravenous morphine milligram equivalents (mg).
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziad Mohamed Mostafa Al-Qousi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865455
- Sponsor's protocol ID
- Adjuvants and Opioid Use in LC
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Labetalol, Magnesium Sulfate or Lidocaine Infusion on Opioid Consumption During Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT07865455
- Acronym / sponsor ID
- Adjuvants and Opioid Use in LC
- Conditions
- Postoperative Pain, Cholelithiasis
- Keywords
- Laparoscopic Cholecystectomy, Labetalol, Magnesium Sulfate, Lidocaine Infusion, Opioid-Sparing Analgesia, Multimodal Analgesia, Opioid Consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Lb: Labetalol Infusion | Experimental | Drug: LabetalolParticipants 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. |
| Group M: Magnesium Sulfate Infusion | Active comparator | Drug: Magnesium SulfateParticipants 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. |
| Group L: Lidocaine Infusion | Active comparator | Drug: LidocaineParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LabetalolAdministered 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. | Drug | Group Lb: Labetalol Infusion |
| Magnesium SulfateAdministered 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. | Drug | Group M: Magnesium Sulfate Infusion |
| LidocaineAdministered 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. | Drug | Group L: Lidocaine Infusion |
Primary outcome
Total 24-Hour Opioid Consumption
Time frame: 24 hours postoperatively
Cumulative amount of intraoperative and postoperative rescue opioids administered, converted to intravenous morphine milligram equivalents (mg).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Labetalol, Magnesium Sulfate and Lidocaine in people with Postoperative Pain and Cholelithiasis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24-Hour Opioid Consumption (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.