CholelithiasesPhase 4NCT06964555
Effect of Intravenous Low-Dose Ketamine Infusion With Intravenous Lignocaine Infusion on Post-Operative Pain in Patients Undergoing Laparoscopic Choleysystectomy Under General Anesthesia
A Phase 4 study testing Intravenous Ketamine Infusions and Intravenous lignocaine in people with Cholelithiases, run by Fazaia Ruth Pfau Medical College at 1 site in Pakistan.
Trial summary
Objective: To determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing LC under general anesthesia in a tertiary care hospital. Sample Selection: Patients of both the gender of age at least 18 years, planned for elective LC with ASA grade I-II were included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiases
- What is being tested?
- Intravenous Ketamine Infusions and Intravenous lignocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to 31 Dec 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both the gender of age at least 18 years
- Patients planned for elective LC
- Patients with ASA grade I-II were included.
Who cannot join
- Patients with obesity,
- Patients with history of alcohol consumptions, uncontrolled hypertension and diabetics,
- Drug abusers
- Patients with chronic pain
- Patients allergic to study drugs
- Patients having neurological disorders or unable to understand pain scoring system
- Patients converted to open LC
Trial locations and contacts
1 site in 1 country.
About this study
Objective: To determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing LC under general anesthesia in a tertiary care hospital.
Sample Selection: Patients of both the gender of age at least 18 years, planned for elective LC with ASA grade I-II were included. Patients with obesity, history of alcohol consumptions, drug abusers, uncontrolled hypertension and diabetics, with chronic pain, allergic to study drugs, having neurological disorders, unable to understand pain scoring system and converted to open LC were excluded.
- Conditions
- Cholelithiases
- Being tested
- Intravenous Ketamine Infusions, Intravenous lignocaine
- Keywords
- Cholelithiases, Cholecystectomy, Laparoscopy
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Ketamine InfusionsDrug
Ketamine group received ketamine at 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery.
Intravenous lignocaineDrug
IV Lignocaine was given at the rate of 1 mg/kg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | Just before the skin incision intravenous lignocaine was given. Receives: Drug: Intravenous lignocaine |
| Group K | Experimental | Just before the skin incision, intravenous ketamine was given Receives: Drug: Intravenous Ketamine Infusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
Pain was assessed using Numeric Rating Scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no and 10 means worst pain.
Measured: 24 hours
Secondary outcomes (2)
Time to rescue analgesia
Time to rescue analgesia was defined as time point at which patient will be given first rescue analgesia for pain of score more 5 or above.
Measured: 24 hours
Wound Closure
The time between the incision and the wound's closure was used to define the length of the surgery.
Measured: End of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start1 Jan 2024
- Primary completion30 Nov 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fazaia Ruth Pfau Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syeda Hajrah Rehman, Fazaia Ruth Pfau Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06964555
- Sponsor's protocol ID
- FRPMC-IRB-2024-41
- Status last verified
- May 2025
- First submitted
- 1 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Low-Dose Ketamine Infusion With Intravenous Lignocaine Infusion on Post-Operative Pain in Patients Undergoing Laparoscopic Choleysystectomy Under General Anesthesia
- ClinicalTrials.gov ID
- NCT06964555
- Acronym / sponsor ID
- FRPMC-IRB-2024-41
- Conditions
- Cholelithiases
- Keywords
- Cholelithiases, Cholecystectomy, Laparoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fazaia Ruth Pfau Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 9 May 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.
Objective: To determine the effect of low-dose ketamine versus lignocaine on post-operative pain in patients undergoing LC under general anesthesia in a tertiary care hospital.
Sample Selection: Patients of both the gender of age at least 18 years, planned for elective LC with ASA grade I-II were included. Patients with obesity, history of alcohol consumptions, drug abusers, uncontrolled hypertension and diabetics, with chronic pain, allergic to study drugs, having neurological disorders, unable to understand pain scoring system and converted to open LC were excluded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: Intravenous lignocaineJust before the skin incision intravenous lignocaine was given. |
| Group K | Experimental | Drug: Intravenous Ketamine InfusionsJust before the skin incision, intravenous ketamine was given |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of both the gender of age at least 18 years
- Patients planned for elective LC
- Patients with ASA grade I-II were included.
Key exclusion criteria (7 listed)
- Patients with obesity,
- Patients with history of alcohol consumptions, uncontrolled hypertension and diabetics,
- Drug abusers
- Patients with chronic pain
- Patients allergic to study drugs
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 |
|---|---|---|
| Intravenous Ketamine InfusionsKetamine group received ketamine at 0.2mg/kg bolus intravenously followed by ketamine infusion at rate of 0.2mg/kg/hr throughout the surgery. | Drug | Group K |
| Intravenous lignocaineIV Lignocaine was given at the rate of 1 mg/kg/hr. | Drug | Group L |
Primary outcome
Post operative Pain
Time frame: 24 hours
Pain was assessed using Numeric Rating Scale which is a ten point scoring scale ranging from 0-10 for ranking pain where 0 means no and 10 means worst pain.
2 secondary outcomes
Time to rescue analgesia
Time frame: 24 hours
Wound Closure
Time frame: End of Surgery
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 22 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Ketamine Infusions and Intravenous lignocaine in people with Cholelithiases, run by Fazaia Ruth Pfau 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 3 inclusion and 7 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 22 May 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 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?
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?
Post operative Pain (time frame: 24 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 22 May 2025.