Acute Post-operative PainPainNCT05214157
Optimizing Pain Management Following Laparoscopic Cholecystectomy RCT
A study testing active gas aspiration in people with Acute Post-operative Pain and Cholecystectomy, Laparoscopic, run by Zagazig University at 1 site in Egypt.
Trial summary
evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity
- What is being tested?
- active gas aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2020to 8 Jan 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who were having symptoms consistent with biliary colic,
- had ultrasound evidence of gall stones,
- classified as American Society of Anesthesiology (ASA) I and II
- ages ranging from 18 to 65 years
Who cannot join
- Patients who refused to give consent,
- pregnant,
- had a history of drug abuse,
- had CBD stones,
- acute cholecystitis,
- acute pancreatitis,
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- previous abdominal surgery,
- history of peritonitis,
- had carcinoma of the gall bladder Patients who were converted to open surgery,
- patients who required placement of drains
- patients with intraoperative complications (CBD injury or liver bed bleeding).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy
evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.
Read the detailed description
Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.
- Conditions
- Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity, Pain Intensity
- Being tested
- active gas aspiration
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active gas aspirationProcedure or surgery
Also called application of Bupivacaine soaked sponge
sucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | interventional group, final two operative steps applied Receives: Procedure: active gas aspiration |
| group B | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain intensity
severity by visual analogue scale
Measured: 6 - 24 hours
Secondary outcomes (1)
hospital stay
numbers of days
Measured: 1-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start20 Mar 2020
- Primary completion31 Dec 2021
- Study completion8 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post-operative PainStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 804 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed lotfy, Zagazig University
- Investigators
- mohamed l ali, md, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214157
- Sponsor's protocol ID
- zuh 243
- Acronym
- Pain
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 28 Jan 2022
- 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 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on the Role of Restoring Liver-Diaphragm Surface Tension and Pain Control at Port Sites in Optimizing Pain Management Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05214157
- Acronym / sponsor ID
- Pain / zuh 243
- Conditions
- Acute Post-operative Pain, Cholecystectomy, Laparoscopic, Pain Assessment Pain Intensity, Pain Intensity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 804 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 8 Jan 2022 (actual)
- First posted
- 28 Jan 2022 (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.
evaluating the two final steps we added to optimize post laparoscopic cholecystectomy pain management.
Detailed description
Introduction: After a laparoscopic cholecystectomy (LC), pain is still a significant concern, leading to extended hospital stays or readmissions. In majority of patients, postoperative pain medications are required. A standardized strategy is needed to offer effective pain relief postoperatively. The majority of pain in the early postoperative period is due to elimination of intraperitoneal surface tension or of parietal type. Aim of the work: to evaluate the two final steps we added to optimize postoperative pain management. Patients and methods: Over the period from March 2020 to December 2021, 816 patients with gallbladder stone undergoing LC were randomized into 2 groups after exclusion of 12 patients: Group A; interventional contained 402 patients. Group B; control contained 402 patients. Post-operative data to be compared were made in terms of operative time, shoulder pain, upper abdominal pain, (at 6,12,18 and 24 hours) and number of analgesic doses and hospital stay. Pain intensity was assessed by using the visual analogue scale (VAS) for each patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Procedure: active gas aspirationinterventional group, final two operative steps applied |
| group B | No intervention | –control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who were having symptoms consistent with biliary colic,
- had ultrasound evidence of gall stones,
- classified as American Society of Anesthesiology (ASA) I and II
- ages ranging from 18 to 65 years
Key exclusion criteria (11 listed)
- Patients who refused to give consent,
- pregnant,
- had a history of drug abuse,
- had CBD stones,
- acute cholecystitis,
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 |
|---|---|---|
| active gas aspirationAlso: application of Bupivacaine soaked spongesucking remaining Co2 from the peritoneal cavity and local anaesthetic application at port sites | Procedure or surgery | group A |
Primary outcome
postoperative pain intensity
Time frame: 6 - 24 hours
severity by visual analogue scale
1 secondary outcome
hospital stay
Time frame: 1-5 days
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 28 Jan 2022.
- 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.
mohamed l ali, md study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active gas aspiration in people with Acute Post-operative Pain and Cholecystectomy, Laparoscopic, run by Zagazig 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 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 28 Jan 2022. 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. 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 pain intensity (time frame: 6 - 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 28 Jan 2022.