Perioperative PainNCT04609033
Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
A study testing Bupivacaine, isotonic saline and Bupivacaine + morphine in people with Perioperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Perioperative Pain
- What is being tested?
- Bupivacaine, isotonic saline and Bupivacaine + morphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Oct 2020to 30 Mar 2021
- Phase
- Interventional
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for Laparoscopic cholecystectomy.
- Age spectrum of 18 - 55 years
- ASA I, II
- Have no comorbid chronic medical diseases
Who cannot join
- Patients with co morbid medical diseases
- Age outside the specified range
- Acute inflammation of the gall bladder
- Critically ill patient
- Emergency operations
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively
Read the detailed description
The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.
The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation
- Conditions
- Perioperative Pain
- Being tested
- Bupivacaine, isotonic saline, Bupivacaine + morphine, Bupivacaine + morphine + ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
isotonic salineDrug
instillation of local anaesthetic in the abdominal cavity at the end of the procedure
Bupivacaine + morphineDrug
instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
Bupivacaine + morphine + ketamineDrug
instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Active comparator | Not described Receives: Drug: Bupivacaine |
| bupivacaine + morphine | Active comparator | Not described Receives: Drug: Bupivacaine + morphine |
| bupivacaine + morphine + ketamine | Active comparator | Not described Receives: Drug: Bupivacaine + morphine + ketamine |
| isotonic saline | Placebo comparator | Not described Receives: Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative level of ACTH hormone
a stress marker that increase with pain and surgery
Measured: 6 hours
Secondary outcomes (1)
VISUUEAL ANALOGE SCORE
to assess postoperative pain
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start24 Oct 2020
- Primary completion1 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esam Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609033
- Sponsor's protocol ID
- 17300477
- Status last verified
- Aug 2021
- First submitted
- 3 Sep 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implications of Different Analgesic Models on Inflammatory Markers After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04609033
- Acronym / sponsor ID
- 17300477
- Conditions
- Perioperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 24 Oct 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 30 Oct 2020 (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.
Postoperative abdominal and shoulder pain that are experienced in patients undergoing laparoscopic cholecystectomy (LC) is significant. Although it is generally less sever than post open cholecystectomy pain, it still causes an avoidable distress in the first 24 hours postoperatively
Detailed description
The incidence of pain after laparoscopy may be as high as 36 to 63 percent and is attributed to the carbon dioxide gas (CO2) used to induce pneumo-peritoneum1.
The residual part of CO2 remains in the peritoneal cavity for several days after the operation and causes stretching of the phrenic nerve endings, local hypothermia, and diaphragmatic irritation by carbonic acid formation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Active comparator | Drug: Bupivacaine |
| bupivacaine + morphine | Active comparator | Drug: Bupivacaine + morphine |
| bupivacaine + morphine + ketamine | Active comparator | Drug: Bupivacaine + morphine + ketamine |
| isotonic saline | Placebo comparator | Drug: isotonic saline |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients scheduled for Laparoscopic cholecystectomy.
- Age spectrum of 18 - 55 years
- ASA I, II
- Have no comorbid chronic medical diseases
Key exclusion criteria (6 listed)
- Patients with co morbid medical diseases
- Age outside the specified range
- Acute inflammation of the gall bladder
- Critically ill patient
- Emergency operations
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 |
|---|---|---|
| Bupivacaineinstillation of local anaesthetic in the abdominal cavity at the end of the procedure | Drug | bupivacaine group |
| isotonic salineinstillation of local anaesthetic in the abdominal cavity at the end of the procedure | Drug | isotonic saline |
| Bupivacaine + morphineinstillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure | Drug | bupivacaine + morphine |
| Bupivacaine + morphine + ketamineinstillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure | Drug | bupivacaine + morphine + ketamine |
Primary outcome
postoperative level of ACTH hormone
Time frame: 6 hours
a stress marker that increase with pain and surgery
1 secondary outcome
VISUUEAL ANALOGE SCORE
Time frame: 24 hours
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 30 Aug 2021.
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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 study testing Bupivacaine, isotonic saline and Bupivacaine + morphine in people with Perioperative Pain, run by Assiut University at 1 site in Egypt.
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 4 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 30 Aug 2021. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 level of ACTH hormone (time frame: 6 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 30 Aug 2021.