Pain, PostoperativePhase 1NCT07248384
The Efface of Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy
A Phase 1 study testing IV ketamine 0.5 mg/kg and IV Lidocain 60 mg/kg in people with Pain, Postoperative, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
This prospective interventional study conducted at Liaquat National Hospital and Medical College compared the analgesic efficacy of ketamine and lidocaine in managing postoperative pain after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- IV ketamine 0.5 mg/kg 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
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2023to 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
- Healthy volunteers accepted
- 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.
Show all 11Show fewer
- 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
Liaquat National Hospital, Anesthesiology Department
Karachi, Sindh, 74800
About this study
Official title: The Efface of Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This prospective interventional study conducted at Liaquat National Hospital and Medical College compared the analgesic efficacy of ketamine and lidocaine in managing postoperative pain after laparoscopic cholecystectomy. Total of 76 ASA I-II patients were randomly assigned into two equal groups (Group K: Ketamine, Group L: Lidocaine) using a sealed-envelope method in a double-blind, placebo-controlled design. Standard anesthesia with propofol, isoflurane, and atracurium was administered, and all patients received postoperative diclofenac sodium and ondansetron. Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The study aimed to compare the pain-relieving effects of ketamine and lidocaine, contributing to improved strategies for postoperative pain management following laparoscopic cholecystectomy.
Read the detailed description
Effective postoperative pain management is essential for promoting patient recovery, reducing stress response, and improving overall outcomes following laparoscopic cholecystectomy. This prospective interventional study was conducted at Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic efficacy of intravenous ketamine and lidocaine in managing postoperative pain among patients undergoing elective laparoscopic cholecystectomy.
A total of 76 ASA grade I and II patients with uncomplicated symptomatic gallstone disease were enrolled after obtaining written informed consent and ethical approval. Using a sealed-envelope randomization method, patients were divided into two equal groups: Group K (n=38) received ketamine, and Group L (n=38) received lidocaine. The study followed a double-blinded, placebo-controlled design to ensure unbiased assessment. Patients with ASA grade III-V, chronic pain, psychiatric illness, pregnancy or lactation, major hepatic, renal, or cardiovascular dysfunction, or a recent history of opioid or NSAID use were excluded.
All participants underwent standard preoperative preparation, including overnight fasting and pre-anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Standard intraoperative monitoring of pulse rate, blood pressure, ECG, SpO₂, and end-tidal CO₂ was performed. Following surgery, residual neuromuscular blockade was reversed with neostigmine. All patients received intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron to prevent postoperative nausea and vomiting.
Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. Patients who reported pain received intravenous Kinz 5 mg as rescue analgesia, with timing recorded by nursing staff.
This study provided valuable insight into the comparative analgesic effects of ketamine and lidocaine for postoperative pain control following laparoscopic cholecystectomy, emphasizing their potential role in multimodal analgesia protocols to enhance patient comfort and recovery.
- Conditions
- Pain, Postoperative
- Being tested
- IV ketamine 0.5 mg/kg, IV Lidocain 60 mg/kg
- Keywords
- Ketamine, Lidocaine, Postoperative Pain, Pain, Laparoscopic Cholecystectomy, Analgesia; Visual Analogue Scale (VAS), Anesthesia, Pain Management
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV ketamine 0.5 mg/kgDrug
Patients in the Ketamine group received intravenous ketamine at a dose of 0.5 mg/kg body weight, diluted with normal saline to a total volume of 10 mL. The prepared solution was administered as a single (stat) intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was administered under aseptic precautions by an anesthetist who was blinded to group allocation.
All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and ondansetron 4 mg IV for nausea prevention. Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was documented.
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 |
|---|---|---|
| Ketamine Group | Active comparator | The ketamine dose was calculated as 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a stat dose during anesthesia reversal, following the completion of surgery. Receives: Drug: IV ketamine 0.5 mg/kg |
| Lidocaine Group | Active comparator | A total of 3 mL of 2% lidocaine was 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 completion of surgery. 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 start15 Jul 2023
- Primary completion20 Aug 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 Pain, PostoperativeStudies 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
- 76 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 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248384
- Sponsor's protocol ID
- 1097-2024-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 Ketamine vs. Lidocaine in the Management of Pain After Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07248384
- Acronym / sponsor ID
- 1097-2024-LNH-ERC
- Conditions
- Pain, Postoperative
- Keywords
- Ketamine, Lidocaine, Postoperative Pain, Pain, Laparoscopic Cholecystectomy, Analgesia; Visual Analogue Scale (VAS), Anesthesia, Pain Management
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 20 Aug 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 conducted at Liaquat National Hospital and Medical College compared the analgesic efficacy of ketamine and lidocaine in managing postoperative pain after laparoscopic cholecystectomy. Total of 76 ASA I-II patients were randomly assigned into two equal groups (Group K: Ketamine, Group L: Lidocaine) using a sealed-envelope method in a double-blind, placebo-controlled design. Standard anesthesia with propofol, isoflurane, and atracurium was administered, and all patients received postoperative diclofenac sodium and ondansetron. Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. The study aimed to compare the pain-relieving effects of ketamine and lidocaine, contributing to improved strategies for postoperative pain management following laparoscopic cholecystectomy.
Detailed description
Effective postoperative pain management is essential for promoting patient recovery, reducing stress response, and improving overall outcomes following laparoscopic cholecystectomy. This prospective interventional study was conducted at Department of Anesthesiology at Liaquat National Hospital and Medical College to compare the analgesic efficacy of intravenous ketamine and lidocaine in managing postoperative pain among patients undergoing elective laparoscopic cholecystectomy.
A total of 76 ASA grade I and II patients with uncomplicated symptomatic gallstone disease were enrolled after obtaining written informed consent and ethical approval. Using a sealed-envelope randomization method, patients were divided into two equal groups: Group K (n=38) received ketamine, and Group L (n=38) received lidocaine. The study followed a double-blinded, placebo-controlled design to ensure unbiased assessment. Patients with ASA grade III-V, chronic pain, psychiatric illness, pregnancy or lactation, major hepatic, renal, or cardiovascular dysfunction, or a recent history of opioid or NSAID use were excluded.
All participants underwent standard preoperative preparation, including overnight fasting and pre-anesthetic evaluation. General anesthesia was induced with propofol and atracurium and maintained with isoflurane. Standard intraoperative monitoring of pulse rate, blood pressure, ECG, SpO₂, and end-tidal CO₂ was performed. Following surgery, residual neuromuscular blockade was reversed with neostigmine. All patients received intravenous diclofenac sodium every 8 hours for baseline analgesia and ondansetron to prevent postoperative nausea and vomiting.
Pain intensity was assessed using the Visual Analogue Scale (VAS) at 1, 6, 12, and 24 hours postoperatively. Patients who reported pain received intravenous Kinz 5 mg as rescue analgesia, with timing recorded by nursing staff.
This study provided valuable insight into the comparative analgesic effects of ketamine and lidocaine for postoperative pain control following laparoscopic cholecystectomy, emphasizing their potential role in multimodal analgesia protocols to enhance patient comfort and recovery.
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 |
|---|---|---|
| Ketamine Group | Active comparator | Drug: IV ketamine 0.5 mg/kgThe ketamine dose was calculated as 0.5 mg/kg of body weight, diluted with normal saline to a total volume of 10 mL, and administered intravenously as a stat dose during anesthesia reversal, following the completion of surgery. |
| Lidocaine Group | Active comparator | Drug: IV Lidocain 60 mg/kgA total of 3 mL of 2% lidocaine was 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 completion of surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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.
Key exclusion criteria (11 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.
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 ketamine 0.5 mg/kgPatients in the Ketamine group received intravenous ketamine at a dose of 0.5 mg/kg body weight, diluted with normal saline to a total volume of 10 mL. The prepared solution was administered as a single (stat) intravenous injection at the time of anesthesia reversal, immediately after completion of laparoscopic cholecystectomy. The drug was administered under aseptic precautions by an anesthetist who was blinded to group allocation. All patients received standard postoperative care, including intravenous diclofenac sodium 75 mg every 8 hours for baseline analgesia and ondansetron 4 mg IV for nausea prevention. Postoperative pain intensity was recorded at 1, 6, 12, and 24 hours using the Visual Analogue Scale (VAS). Patients reporting significant pain were administered intravenous Kinz 5 mg as rescue analgesia, and the timing of administration was documented. | Drug | Ketamine 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
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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
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 ketamine 0.5 mg/kg and IV Lidocain 60 mg/kg in people with Pain, Postoperative, 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 6 inclusion and 11 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.