Laparoscopic Cholecystectomy SurgeryPhase 1NCT07248332
The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy
A Phase 1 study testing IV 2mg of Magnesium Sulphate and IV Lidocain 60 mg/kg in people with Laparoscopic Cholecystectomy Surgery and Postoperative Pain Management, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
This prospective interventional study was carried out at Liaquat National Hospital and Medical College to evaluate and compare the postoperative analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery, Postoperative Pain Management
- What is being tested?
- IV 2mg of Magnesium Sulphate and IV Lidocain 60 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Jan 2024to 30 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years. ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age
Who cannot join
- • ASA III-V patients. Allergy or hypersensitivity to ketamine, lidocaine, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery. Inability to understand or report pain postoperatively.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Anesthesiology Department Liaquat National Hospital and Medical College
Karachi, Sindh, 78400
About this study
Official title: The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This prospective interventional study was carried out at Liaquat National Hospital and Medical College to evaluate and compare the postoperative analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 168 ASA I-II patients were enrolled and randomly allocated into two groups of 84 participants each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope randomization technique in a double-blind, placebo-controlled design. All patients received standardized general anesthesia with propofol, isoflurane, and atracurium, and routine postoperative care included intravenous diclofenac sodium and ondansetron. Postoperative pain was measured at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS) to assess and compare the efficacy and duration of analgesia between the two groups. The study aimed to provide insight into the relative analgesic performance of lidocaine and magnesium sulphate, supporting improved pain management strategies following laparoscopic cholecystectomy.
Read the detailed description
Optimal management of postoperative pain is crucial for enhancing recovery, minimizing stress responses, and promoting better outcomes after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing elective laparoscopic cholecystectomy.
A total of 168 patients classified as ASA I-II with uncomplicated symptomatic gallstones were enrolled after obtaining ethical approval and written informed consent. Participants were randomly assigned into two equal groups of 84 patients each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope technique. The study employed a double-blind, placebo-controlled design to ensure unbiased evaluation. Patients with ASA III-V, chronic pain disorders, psychiatric conditions, pregnancy or breastfeeding, major hepatic, renal, or cardiovascular disease, or recent use of opioids or NSAIDs were excluded from the study.
All patients underwent standard preoperative assessment, including overnight fasting and anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Intraoperative monitoring included heart rate, blood pressure, ECG, oxygen saturation, and end-tidal CO₂. Residual neuromuscular blockade was reversed with neostigmine at the end of surgery. Postoperative care included intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron for prevention of nausea and vomiting.
Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients experiencing significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing was documented by nursing staff.
This study provided important information on the comparative efficacy of lidocaine and magnesium sulphate for postoperative pain management, highlighting their potential role in multimodal analgesic strategies to improve patient comfort and recovery following laparoscopic cholecystectomy.
- Being tested
- IV 2mg of Magnesium Sulphate, IV Lidocain 60 mg/kg
- Keywords
- Lidocaine, Magnesium Sulphate, Postoperative Pain, Laparoscopic Cholecystectomy, Visual Analogue Scale (VAS), analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV 2mg of Magnesium SulphateDrug
Patients in the magnesium sulfate group received 2 mg of the drug, which was diluted with normal saline to a total volume of 10 mL and administered intravenously as a single stat dose at the time of anesthesia reversal following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation.
IV Lidocain 60 mg/kgDrug
Patients in the Lidocaine group received 3 mL of 2% lidocaine, diluted with 7 mL of normal saline to prepare a 10 mL solution, which was administered intravenously as a stat dose at the time of anesthesia reversal, immediately after surgery. The intervention was given using the same protocol and blinding method as the Ketamine group to maintain uniformity. Similar to Group K, all patients received standard postoperative medications, including IV diclofenac sodium and ondansetron. Pain assessment was performed using the VAS scale at 1, 6, 12, and 24 hours postoperatively. Patients requiring additional pain relief were given IV Kinz 5 mg as rescue analgesia, with the time of each administration noted.
| Study group | Role | What they receive |
|---|---|---|
| Magnesium Sulphate Group | Active comparator | The magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery. Receives: Drug: IV 2mg of Magnesium Sulphate |
| Lidocaine Group | Active comparator | A total of 3 mL of 2% lidocaine was combined with 7 mL of normal saline to prepare a 10 mL solution, which was given intravenously as a single stat dose at the time of anesthesia reversal immediately after the surgery was completed. Receives: Drug: IV Lidocain 60 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to evaluate and compare the effectiveness and duration of analgesia between the ketamine and lidocaine groups. These time intervals were selected to monitor both the early and late postoperative pain responses during the first 24 hours of recovery.
Measured: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start18 Jan 2024
- Primary completion15 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Cholecystectomy SurgeryStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hussain Imam, Liaquat National Hospital & Medical College
- Investigators
- Mustafa Hussain Imam, MBBS, Principal investigator, Liaquat National HospitalAli Asgher, Mbbs, FCPS, Study director, Liaquat National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248332
- Sponsor's protocol ID
- 1095-2024-LNH-ERC
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efface of Lidocaine vs. Magnesium Sulphate in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07248332
- Acronym / sponsor ID
- 1095-2024-LNH-ERC
- Keywords
- Lidocaine, Magnesium Sulphate, Postoperative Pain, Laparoscopic Cholecystectomy, Visual Analogue Scale (VAS), analgesia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 25 Nov 2025 (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.
This prospective interventional study was carried out at Liaquat National Hospital and Medical College to evaluate and compare the postoperative analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing laparoscopic cholecystectomy. A total of 168 ASA I-II patients were enrolled and randomly allocated into two groups of 84 participants each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope randomization technique in a double-blind, placebo-controlled design. All patients received standardized general anesthesia with propofol, isoflurane, and atracurium, and routine postoperative care included intravenous diclofenac sodium and ondansetron. Postoperative pain was measured at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS) to assess and compare the efficacy and duration of analgesia between the two groups. The study aimed to provide insight into the relative analgesic performance of lidocaine and magnesium sulphate, supporting improved pain management strategies following laparoscopic cholecystectomy.
Detailed description
Optimal management of postoperative pain is crucial for enhancing recovery, minimizing stress responses, and promoting better outcomes after laparoscopic cholecystectomy. This prospective interventional study was carried out in the Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic effects of intravenous lidocaine and magnesium sulphate in patients undergoing elective laparoscopic cholecystectomy.
A total of 168 patients classified as ASA I-II with uncomplicated symptomatic gallstones were enrolled after obtaining ethical approval and written informed consent. Participants were randomly assigned into two equal groups of 84 patients each (Group L: Lidocaine, Group M: Magnesium Sulphate) using a sealed-envelope technique. The study employed a double-blind, placebo-controlled design to ensure unbiased evaluation. Patients with ASA III-V, chronic pain disorders, psychiatric conditions, pregnancy or breastfeeding, major hepatic, renal, or cardiovascular disease, or recent use of opioids or NSAIDs were excluded from the study.
All patients underwent standard preoperative assessment, including overnight fasting and anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Intraoperative monitoring included heart rate, blood pressure, ECG, oxygen saturation, and end-tidal CO₂. Residual neuromuscular blockade was reversed with neostigmine at the end of surgery. Postoperative care included intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron for prevention of nausea and vomiting.
Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients experiencing significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing was documented by nursing staff.
This study provided important information on the comparative efficacy of lidocaine and magnesium sulphate for postoperative pain management, highlighting their potential role in multimodal analgesic strategies to improve patient comfort and recovery following laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnesium Sulphate Group | Active comparator | Drug: IV 2mg of Magnesium SulphateThe magnesium sulfate dose was prepared as 2 mg, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a single stat dose at the time of anesthesia reversal after completion of surgery. |
| Lidocaine Group | Active comparator | Drug: IV Lidocain 60 mg/kgA total of 3 mL of 2% lidocaine was combined with 7 mL of normal saline to prepare a 10 mL solution, which was given intravenously as a single stat dose at the time of anesthesia reversal immediately after the surgery was completed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-65 years. ASA physical status I-II. Elective laparoscopic cholecystectomy planned under general anesthesia. Normal baseline renal, hepatic, and coagulation profile. Able to give informed consent and communicate pain scores. Negative pregnancy test for women of childbearing age
Key exclusion criteria (1 listed)
- • ASA III-V patients. Allergy or hypersensitivity to ketamine, lidocaine, or related drugs. History of psychiatric illness or substance abuse. Chronic use of opioids, benzodiazepines, or MAO inhibitors. Pregnant or breastfeeding women. Chronic pain disorders or use of analgesics within 7 days pre-op. Major hepatic, renal, or cardiovascular dysfunction. History of myopathy or seizure disorders. Patients with atrioventricular block or on calcium-channel blockers. Conversion to open cholecystectomy during surgery. Inability to understand or report pain postoperatively.
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 |
|---|---|---|
| IV 2mg of Magnesium SulphatePatients in the magnesium sulfate group received 2 mg of the drug, which was diluted with normal saline to a total volume of 10 mL and administered intravenously as a single stat dose at the time of anesthesia reversal following completion of laparoscopic cholecystectomy. The injection was performed under aseptic conditions by an anesthetist who was blinded to group assignment. All participants received routine postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline pain control and intravenous ondansetron 4 mg to prevent nausea. Postoperative pain intensity was measured using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours. Patients experiencing significant pain were given intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was recorded for documentation. | Drug | Magnesium Sulphate Group |
| IV Lidocain 60 mg/kgPatients in the Lidocaine group received 3 mL of 2% lidocaine, diluted with 7 mL of normal saline to prepare a 10 mL solution, which was administered intravenously as a stat dose at the time of anesthesia reversal, immediately after surgery. The intervention was given using the same protocol and blinding method as the Ketamine group to maintain uniformity. Similar to Group K, all patients received standard postoperative medications, including IV diclofenac sodium and ondansetron. Pain assessment was performed using the VAS scale at 1, 6, 12, and 24 hours postoperatively. Patients requiring additional pain relief were given IV Kinz 5 mg as rescue analgesia, with the time of each administration noted. | Drug | Lidocaine Group |
Primary outcome
Postoperative Pain Score
Time frame: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours.
Postoperative pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours after surgery to evaluate and compare the effectiveness and duration of analgesia between the ketamine and lidocaine groups. These time intervals were selected to monitor both the early and late postoperative pain responses during the first 24 hours of recovery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mustafa Hussain Imam, MBBS principal investigator
Liaquat National Hospital
Ali Asgher, Mbbs, FCPS study director
Liaquat National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV 2mg of Magnesium Sulphate and IV Lidocain 60 mg/kg in people with Laparoscopic Cholecystectomy Surgery and Postoperative Pain Management, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative Pain Score (time frame: Postoperative pain was assessed at the 1st, 6th, 12th, and 24th hours.). 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 25 Nov 2025.