Laparoscopic Cholecystectomy SurgeryEarly Phase 1NCT06807554
Intraperitoneal Ketamine Versus Bupivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy
A Early Phase 1 study testing Ketamine and Bupivacaine in people with Laparoscopic Cholecystectomy Surgery, run by Liaquat National Hospital & Medical College at 1 site in Pakistan.
Trial summary
The intraperitoneal approach is used in anesthesia to manage the pain associated with abdominal procedures. Few studies have been conducted comparing intraperitonela ketamine with bupivacaine for pain control in laparoscopic cholecystectomy (LC) patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Ketamine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 1 Jul 2022
- Phase
- Early 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of age 20-70 years
- Patients of either gender
- Patients planned to undergo elective LC
Who cannot join
- Patients known to allergic to study drugs
- Patients with chronic pain conditions
- Patients taking chronic pain medications
- Patients having psychiatric illness
- Patients weighing more than 80 kg,
- Emergency surgery and/or converted to open cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
The intraperitoneal approach is used in anesthesia to manage the pain associated with abdominal procedures. Few studies have been conducted comparing intraperitonela ketamine with bupivacaine for pain control in laparoscopic cholecystectomy (LC) patients. To compare effect of intraperitoneal ketamine versus bupivacaine for postoperative pain control after LC. Department of Anesthesiology, Critical Care and Pain Management, Liaquat National Hospital and Medical College, Karachi. Group K received ketamine whereas Group B received bupivacaine. In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon. In Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml was administered. Tramadol 1.5 mg/kg to a maximum of 100 mg IV was given as rescue analgesia. The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
Read the detailed description
Proper pain management encourages quick ambling, reduces the likelihood of pulmonary embolism and deep vein thrombosis, enhances the patient's ability to breathe deeply, which reduces the possibility of pulmonary complications, and reduces tachycardia and the unnecessary investigations that are linked to it. Few studies have been conducted comparing intraperitoneal ketamine with bupivacaine for pain control in LC patients. Thus we planned the current study to compare effect of intraperitoneal ketamine versus bupivacaine for post-surgery pain control after LC.
This double blinded randomized controlled trial was performed in Operation theatre, Department of Anesthesiology, Critical Care and Pain Management, Liaquat National Hospital and Medical College, Karachi, Pakistan. The study was commenced with the institutional ethical approval. The study included all ASA I and II patients, male or female, aged 20 to 70, who were planned to undergo elective LC. Patients with known allergies to study drugs with any chronic pain condition, taking chronic pain medications, having psychiatric illness, weighing more than 80 kg, emergency surgery and converted to open cholecystectomy were excluded. Patients were enrolled with their written informed consent.
Sample size of 46 per arm was estimated using online available calculator Open-Epi, by taking mean VAS score of 3.0±0.86 in ketamine group and 3.50±0.84 in bupivacaine group at 12 hour at power of 80% and 95% confidence interval. Patients were enrolled using a consecutive sampling procedure, while groups were assigned at random using opaque, sealed envelopes that were consecutively numbered.
In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver. In Group B, bupivacaine 2mg/kg diluted in normal saline to a total volume of 40ml was administered in similar way as described in Group K.
Patients' demographic profile including age, gender, body mass index (BMI), clinical profile comorbidity, ASA grade, surgery duration and pain status were documented. Weight (kg) divided by the square of height (m) was the definition of BMI. Co-morbidities of patients was confirmed from previous medical records or evidence against medication to treat underlying condition.
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Being tested
- Ketamine, Bupivacaine
- Keywords
- Laparoscopic surgery, Ketamine, Bupivacaine, Intraperitoneal instillation, Cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver.
BupivacaineDrug
Also called Active compitator
In Group B, bupivacaine at a dose of 2 mg/kg was diluted in normal saline to a total volume of 40 ml. The administration was performed by the surgeon in two stages: the first 20 ml was instilled before starting the gall bladder dissection, applied over the surgical site and liver, while the remaining 20 ml was instilled at the end of the procedure after achieving hemostasis, applied over the gall bladder bed and liver.
| Study group | Role | What they receive |
|---|---|---|
| Group K | Experimental | In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver. Receives: Drug: Ketamine |
| Group B | Active comparator | In Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml . Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain status
The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
Measured: 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaquat National Hospital & Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shehrum Bughio, Liaquat National Hospital & Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807554
- Sponsor's protocol ID
- Liaquat National Hospital
- Status last verified
- Feb 2025
- First submitted
- 29 Jan 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ziaei P, Kargar S, Dehghan MH, Madadizadeh F, Jamshidi HR. Clinical Trial of Intraperitoneal Administration of Ketamine Combined with Bupivacaine on Pain Status after Laparoscopic Cholecystectomy. Journal of Shahid Sadoughi University of Medical Sciences. 2022.
Mostafa, R.H. and Mekki, Y.M.H., 2018. Comparative evaluation of intraperitoneal bupivacaine and bupivacaine ketamine combined with lung recruitment for reducing postoperative shoulder pain in laparoscopic cholecystectomy. Egyptian Journal of Anaesthesia, 34(4), pp.159-164.
Moharari RS, Hadavi M, Pourfakhr P, Najafi A, Etezadi F, Khajavi MR. Evaluation of the postoperative analgesic efficacy of intraperitoneal ketamine compared with bupivacaine in laparoscopic cholecystectomy. Arch Anesthesiol Crit Care. 2016;2(1):146-9.
Bughio S, Nadeem SM, Rahman A, Kasi PK, Hussain S, Tanwani H. Intraperitoneal ketamine versus bupivacaine for postoperative pain control after laparoscopic cholecystectomy - a double-blind randomized controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):500. doi: 10.1186/s12871-025-03386-3.
PubMed 41087934
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Ketamine Versus Bupivacaine for Postoperative Pain Control After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06807554
- Acronym / sponsor ID
- Liaquat National Hospital
- Conditions
- Laparoscopic Cholecystectomy Surgery
- Keywords
- Laparoscopic surgery, Ketamine, Bupivacaine, Intraperitoneal instillation, Cholecystectomy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Liaquat National Hospital & Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 4 Feb 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.
The intraperitoneal approach is used in anesthesia to manage the pain associated with abdominal procedures. Few studies have been conducted comparing intraperitonela ketamine with bupivacaine for pain control in laparoscopic cholecystectomy (LC) patients. To compare effect of intraperitoneal ketamine versus bupivacaine for postoperative pain control after LC. Department of Anesthesiology, Critical Care and Pain Management, Liaquat National Hospital and Medical College, Karachi. Group K received ketamine whereas Group B received bupivacaine. In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon. In Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml was administered. Tramadol 1.5 mg/kg to a maximum of 100 mg IV was given as rescue analgesia. The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
Detailed description
Proper pain management encourages quick ambling, reduces the likelihood of pulmonary embolism and deep vein thrombosis, enhances the patient's ability to breathe deeply, which reduces the possibility of pulmonary complications, and reduces tachycardia and the unnecessary investigations that are linked to it. Few studies have been conducted comparing intraperitoneal ketamine with bupivacaine for pain control in LC patients. Thus we planned the current study to compare effect of intraperitoneal ketamine versus bupivacaine for post-surgery pain control after LC.
This double blinded randomized controlled trial was performed in Operation theatre, Department of Anesthesiology, Critical Care and Pain Management, Liaquat National Hospital and Medical College, Karachi, Pakistan. The study was commenced with the institutional ethical approval. The study included all ASA I and II patients, male or female, aged 20 to 70, who were planned to undergo elective LC. Patients with known allergies to study drugs with any chronic pain condition, taking chronic pain medications, having psychiatric illness, weighing more than 80 kg, emergency surgery and converted to open cholecystectomy were excluded. Patients were enrolled with their written informed consent.
Sample size of 46 per arm was estimated using online available calculator Open-Epi, by taking mean VAS score of 3.0±0.86 in ketamine group and 3.50±0.84 in bupivacaine group at 12 hour at power of 80% and 95% confidence interval. Patients were enrolled using a consecutive sampling procedure, while groups were assigned at random using opaque, sealed envelopes that were consecutively numbered.
In Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver. In Group B, bupivacaine 2mg/kg diluted in normal saline to a total volume of 40ml was administered in similar way as described in Group K.
Patients' demographic profile including age, gender, body mass index (BMI), clinical profile comorbidity, ASA grade, surgery duration and pain status were documented. Weight (kg) divided by the square of height (m) was the definition of BMI. Co-morbidities of patients was confirmed from previous medical records or evidence against medication to treat underlying condition.
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 |
|---|---|---|
| Group K | Experimental | Drug: KetamineIn Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver. |
| Group B | Active comparator | Drug: BupivacaineIn Group B, bupivacaine 2mg/kgdiluted in normal saline to a total volume of 40ml . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of age 20-70 years
- Patients of either gender
- Patients planned to undergo elective LC
Key exclusion criteria (6 listed)
- Patients known to allergic to study drugs
- Patients with chronic pain conditions
- Patients taking chronic pain medications
- Patients having psychiatric illness
- Patients weighing more than 80 kg,
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 |
|---|---|---|
| KetamineIn Group K, ketamine 0.25mg/kg diluted in normal saline to a total volume of 40 ml was instilled by the surgeon, 20 ml before starting gall bladder dissection over the surgical site and liver while remaining 20 ml at the end of procedure after securing haemostasis over gall bladder bed and liver. | Drug | Group K |
| BupivacaineAlso: Active compitatorIn Group B, bupivacaine at a dose of 2 mg/kg was diluted in normal saline to a total volume of 40 ml. The administration was performed by the surgeon in two stages: the first 20 ml was instilled before starting the gall bladder dissection, applied over the surgical site and liver, while the remaining 20 ml was instilled at the end of the procedure after achieving hemostasis, applied over the gall bladder bed and liver. | Drug | Group B |
Primary outcome
pain status
Time frame: 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
The pain was assessed using a numeric rating scale (NRS) with zero being no pain to ten being the worst possible pain. Pain was assessed using NRS at 0 hour (immediate postoperative period), 2 hour, 4 hour, 6 hour and 12 hours postoperatively.
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 7 Feb 2025.
- BackgroundZiaei P, Kargar S, Dehghan MH, Madadizadeh F, Jamshidi HR. Clinical Trial of Intraperitoneal Administration of Ketamine Combined with Bupivacaine on Pain Status after Laparoscopic Cholecystectomy. Journal of Shahid Sadoughi University of Medical Sciences. 2022.
- BackgroundMostafa, R.H. and Mekki, Y.M.H., 2018. Comparative evaluation of intraperitoneal bupivacaine and bupivacaine ketamine combined with lung recruitment for reducing postoperative shoulder pain in laparoscopic cholecystectomy. Egyptian Journal of Anaesthesia, 34(4), pp.159-164.
- BackgroundMoharari RS, Hadavi M, Pourfakhr P, Najafi A, Etezadi F, Khajavi MR. Evaluation of the postoperative analgesic efficacy of intraperitoneal ketamine compared with bupivacaine in laparoscopic cholecystectomy. Arch Anesthesiol Crit Care. 2016;2(1):146-9.
- Derived from this study: PubMed 41087934Bughio S, Nadeem SM, Rahman A, Kasi PK, Hussain S, Tanwani H. Intraperitoneal ketamine versus bupivacaine for postoperative pain control after laparoscopic cholecystectomy - a double-blind randomized controlled trial. BMC Anesthesiol. 2025 Oct 14;25(1):500. doi: 10.1186/s12871-025-03386-3.
- 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 Early Phase 1 study testing Ketamine and Bupivacaine in people with Laparoscopic Cholecystectomy Surgery, 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 3 inclusion and 6 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 7 Feb 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
pain status (time frame: 2 hour, 4 hour, 6 hour and 12 hours postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06807554, which also lists 4 linked publications.
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 7 Feb 2025.