PainPhase 4NCT02037711
Intraperitoneal Application of Levobupivacaine During Laparoscopic Surgery in Kids.
A Phase 4 study testing Levobupivacaine 0.5% and Normal saline in people with Pain, run by Cairo University at 1 site in Egypt.
Trial summary
Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Levobupivacaine 0.5% and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- May 2013to Nov 2013
- Phase
- Phase 4
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patient undergoing laparoscopic surgeries
- Pediatric weighing 4 kg or more
- Patients with free medical history
Who cannot join
- Parents refusal
- Known allergy to levobupivacaine
- Acute preoperative pain other than biliary colic
- chronic pain treatment or antiepileptic therapy
- Severe hepatic or renal impairment
- Cognitive impairment or communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures
Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.
The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.
-But these methods are not widely used in pediatrics upon our knowledge
- Conditions
- Pain
- Being tested
- Levobupivacaine 0.5%, Normal saline
- Keywords
- Laparoscopic, Levobupivacaine, Pediatric, Anesthesia, Instillation, surgeries
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levobupivacaine 0.5%Drug
Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg.
Normal salineDrug
Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain
| Study group | Role | What they receive |
|---|---|---|
| Chirocaine group (levobupivacaine ) | Active comparator | Not described Receives: Drug: Levobupivacaine 0.5% |
| Control group | Sham comparator | Not described Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain scoring (CHEOPS)
pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.
Measured: up to six hours
Secondary outcomes (2)
changes in Haemodynamics including ( Heart Rate)
Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)
Measured: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6
changes in Haemodynamics including ( Non Invasive Blood Pressure)
Represented as mean and standard deviation, hemodynamic variables will be measured during the the surgery starting preoperatively, following induction of anesthesia, during the procedure and postoperatively (6 hours postoperative)
Measured: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Mohamed Abd el moneim Soaida, MD, Cairo University
- Investigators
- Saad El Basha, M.D., Study chair, Cairo UniversityMaha Gmail, M.D., Study director, Cairo UniversitySherif M Soaida, M.D., Study director, Cairo Universityhagar H Refaee, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037711
- Sponsor's protocol ID
- SMS2013
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2013
- Last updated
- 5 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Instillation of Levobupivacaine in Laparoscopic Pediatric Procedures
- ClinicalTrials.gov ID
- NCT02037711
- Acronym / sponsor ID
- SMS2013
- Conditions
- Pain
- Keywords
- Laparoscopic, Levobupivacaine, Pediatric, Anesthesia, Instillation, surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 16 Jan 2014 (estimated)
- 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.
Pain after laparoscopic surgery has been associated with surgical manipulations, including intraperitoneal insufflation of carbon dioxide (CO2), resulting in peritoneal stretching, diaphragmatic irritation, changes in intra-abdominal pH, and retention of the insufflated gas in the abdominal cavity after surgery. These effects may result in the irritation of peritoneal nerves causing visceral pain, as commonly reported after laparoscopic procedures in pediatrics.
The study hypothesis is that Intraperitoneal local anesthetic (levobupivacaine) instillation can provide pain relief after laparoscopic surgery, but local anesthetic distribution may not always be uniform throughout the peritoneal surface. Many methods were tried for intraperitoneal application of local anesthetics in laparoscopic surgery such as local anesthetic (LA) instillation and LA nebulization.
-But these methods are not widely used in pediatrics upon our knowledge
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chirocaine group (levobupivacaine ) | Active comparator | Drug: Levobupivacaine 0.5% |
| Control group | Sham comparator | Drug: Normal saline |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient undergoing laparoscopic surgeries
- Pediatric weighing 4 kg or more
- Patients with free medical history
Key exclusion criteria (6 listed)
- Parents refusal
- Known allergy to levobupivacaine
- Acute preoperative pain other than biliary colic
- chronic pain treatment or antiepileptic therapy
- Severe hepatic or renal impairment
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 |
|---|---|---|
| Levobupivacaine 0.5%Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg. | Drug | Chirocaine group (levobupivacaine ) |
| Normal salineGroup II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain | Drug | Control group |
Primary outcome
Postoperative Pain scoring (CHEOPS)
Time frame: up to six hours
pain score will be assessed immediately postoperative, then after 1 hour, 2 hours, and 6 hours.
2 secondary outcomes
changes in Haemodynamics including ( Heart Rate)
Time frame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2-6
changes in Haemodynamics including ( Non Invasive Blood Pressure)
Time frame: during the period of the operation (Preoperative, post-induction, after instillation of levobupivacaine or saline, postoperative for 6 hours at 0-1-2- 6
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 5 Aug 2016.
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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.
Saad El Basha, M.D. study chair
Cairo University
Maha Gmail, M.D. study director
Cairo University
Sherif M Soaida, M.D. study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine 0.5% and Normal saline in people with Pain, run by Cairo 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 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 5 Aug 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Postoperative Pain scoring (CHEOPS) (time frame: up to six 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 5 Aug 2016; AzTrials last refreshed its copy on 8 Nov 2026.