Laparoscopic CholecystectomyPhase 3NCT04788654
Multimodal Analgesia for Cholecystectomy
A Phase 3 study testing Celebrex, acetaminophen, and dexamethasone and Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum in people with Laparoscopic Cholecystectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Celebrex, acetaminophen, and dexamethasone and Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2021to 31 Jul 2021
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy
Who cannot join
- Recent gastric ulcer disease
- Hepatic or renal insufficiency
- Opioid dependency
- Coagulopathy
- Pre-existing neurologic or anatomic deficits in the lower extremities
- Severe psychiatric illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions
It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Celebrex, acetaminophen, and dexamethasone, Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum
- Keywords
- postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celebrex, acetaminophen, and dexamethasoneDrug
Also called Pharmacological
Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.
Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneumProcedure or surgery
Also called Surgical
Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacological group | Active comparator | Pharmacological analgesia will be performed Receives: Drug: Celebrex, acetaminophen, and dexamethasone |
| Pharmacologican and surgical group | Experimental | Pharmacological and surgical analgesia will be performed. Receives: Drug: Celebrex, acetaminophen, and dexamethasone; Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve of postoperative pain for 24 hour
Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).
Measured: At postoperative 24 hour
Secondary outcomes (3)
Postoperative pain score,
Postoperative pain score: postoperative pain score will be measured at postoperative 0, 2, 6, and 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).
Measured: At postoperative 0, 2, 6, and 24 hour
Analgesic requirements,
Analgesic requirements will be measured at postoperative 24 hour. Total dose of tramadol, ketorolac, and pethidine will be assessed at postoperative 24 hour.
Measured: At postoperative 24 hour
Sleep quality
Sleep quality will be measured using sleep quality questionnare at postoperative 24 hour.
using sleep quality questionnare.
Measured: At postoperative 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start17 Mar 2021
- Primary completion30 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do-Hyeong Kim, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788654
- Sponsor's protocol ID
- 3-2020-0494
- Status last verified
- Oct 2023
- First submitted
- 16 Feb 2021
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions
- ClinicalTrials.gov ID
- NCT04788654
- Acronym / sponsor ID
- 3-2020-0494
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- postoperative pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 9 Mar 2021 (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.
It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacological group | Active comparator | Drug: Celebrex, acetaminophen, and dexamethasonePharmacological analgesia will be performed |
| Pharmacologican and surgical group | Experimental | Drug: Celebrex, acetaminophen, and dexamethasone, Procedure: Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneumPharmacological and surgical analgesia will be performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (7 listed)
- Recent gastric ulcer disease
- Hepatic or renal insufficiency
- Opioid dependency
- Coagulopathy
- Pre-existing neurologic or anatomic deficits in the lower extremities
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 |
|---|---|---|
| Celebrex, acetaminophen, and dexamethasoneAlso: PharmacologicalPharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively. | Drug | Pharmacological group, Pharmacologican and surgical group |
| Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneumAlso: SurgicalSurgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed. | Procedure or surgery | Pharmacologican and surgical group |
Primary outcome
Area under curve of postoperative pain for 24 hour
Time frame: At postoperative 24 hour
Area under curve will be measured using Postoperative pain score at postoperative 24 hour using visual anlogue scale (0: no pain, 10: most imaginable pain).
3 secondary outcomes
Postoperative pain score,
Time frame: At postoperative 0, 2, 6, and 24 hour
Analgesic requirements,
Time frame: At postoperative 24 hour
Sleep quality
Time frame: At postoperative 24 hour
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 6 Oct 2023.
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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 3 study testing Celebrex, acetaminophen, and dexamethasone and Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum in people with Laparoscopic Cholecystectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
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 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 6 Oct 2023. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Area under curve of postoperative pain for 24 hour (time frame: At postoperative 24 hour). 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 6 Oct 2023.