Post-Operative PainNCT04964180
Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy
A study testing Indomethacin suppository and Lidocaine 2% Injectable Solution in people with Post-Operative Pain, run by South Valley University at 1 site in Egypt.
Trial summary
Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-Operative Pain
- What is being tested?
- Indomethacin suppository and Lidocaine 2% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 20 Jun 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- .ASA physical status 1-2 patients.
- 18-60 years old .
Who cannot join
- using or allergic to nonsteroidal anti inflammatory drugs (NSAIDs) or aspirin .
- history of serious hepatic disease.
- renal or gastrointestinal disease.
- bleeding disorder.
- body mass index BMI <18 or ˃30 m2/kg.
- history of abdominal surgery or chronic pain disorder other than gallbladder.
- disease or allergy to lidocaine.
Trial locations and contacts
1 site in 1 country.
About this study
Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position.
At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
- Conditions
- Post-Operative Pain
- Being tested
- Indomethacin suppository, Lidocaine 2% Injectable Solution
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin suppositoryDrug
Also called Indocid suppository
two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
Lidocaine 2% Injectable SolutionDrug
Also called lidocaine HCL 2%
200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation
| Study group | Role | What they receive |
|---|---|---|
| indomethacin group | Active comparator | group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery Receives: Drug: Indomethacin suppository |
| intraperitoneal lidocaine | Active comparator | 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position Receives: Drug: Lidocaine 2% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS scores postoperative
a standard 10-cm VAS was used, where one end of the scale represented no pain (0 cm), and the other end the most severe pain imaginable (10 cm), the distance in centimeters being taken as the pain score
Measured: 24 hours posoperative
postoperative opoiods analgesics requirements
we used (iv pethidine )whenever the patient complained of pain. IV pethidine injection 25-50 mg was given as rescue analgesic whenever the patient experienced pain ≥ to 5 VAS
Measured: 24 hours postoperative
Secondary outcomes (1)
Pain starting time after surgery and Pethidine required first time.
Pain starting time after surgery and Pethidine required first time.
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start1 May 2020
- Primary completion30 May 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gad Sayed Gad, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04964180
- Sponsor's protocol ID
- analgesia LC
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 15 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Indomethacin Versus Intraperitoneal Lidocaine for Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04964180
- Acronym / sponsor ID
- analgesia LC
- Conditions
- Post-Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 15 Jul 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.
Hospitals, Qena, Egypt in period between May 2020 to May 2021.eighty patients was scheduled to elective laparoscopic cholecystectomy , divided Into two groups randomly using closed envelop method. Group IP lidocaine(40 patients ) received 200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position.
At the end of the laparoscopic procedure, group indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| indomethacin group | Active comparator | Drug: Indomethacin suppositorygroup indomethacin (40 patients) recived two 100 mg indomethacin rectal suppositories 2 hours prior to surgery |
| intraperitoneal lidocaine | Active comparator | Drug: Lidocaine 2% Injectable Solution200 ml saline containing 200 mg 2%lidocaine immediately after abdominal cO2 insufflation( pneumoperitoneum) the surgeon sprayed the total solution on the upper surface of the liver under the right subdiaphragmatic space, left subdiaphragmatic space and around the cholecystectomy site , all patients were maintained in trendelenberg position |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- .ASA physical status 1-2 patients.
- 18-60 years old .
Key exclusion criteria (7 listed)
- using or allergic to nonsteroidal anti inflammatory drugs (NSAIDs) or aspirin .
- history of serious hepatic disease.
- renal or gastrointestinal disease.
- bleeding disorder.
- body mass index BMI <18 or ˃30 m2/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 |
|---|---|---|
| Indomethacin suppositoryAlso: Indocid suppositorytwo 100 mg indomethacin rectal suppositories 2 hours prior to surgery | Drug | indomethacin group |
| Lidocaine 2% Injectable SolutionAlso: lidocaine HCL 2%200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation | Drug | intraperitoneal lidocaine |
Primary outcome
VAS scores postoperative
Time frame: 24 hours posoperative
a standard 10-cm VAS was used, where one end of the scale represented no pain (0 cm), and the other end the most severe pain imaginable (10 cm), the distance in centimeters being taken as the pain score
postoperative opoiods analgesics requirements
Time frame: 24 hours postoperative
we used (iv pethidine )whenever the patient complained of pain. IV pethidine injection 25-50 mg was given as rescue analgesic whenever the patient experienced pain ≥ to 5 VAS
1 secondary outcome
Pain starting time after surgery and Pethidine required first time.
Time frame: 24 hours postoperative
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 15 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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 Indomethacin suppository and Lidocaine 2% Injectable Solution in people with Post-Operative Pain, run by South Valley 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 2 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 15 Jul 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. 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?
VAS scores postoperative (time frame: 24 hours posoperative). The study lists 2 primary outcomes in all. 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 15 Jul 2021.