Pain, PostoperativePhase 4IPLANCT01886352
Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
A Phase 4 study testing Standard Injection of Levobupivacaine in portal sites., Additional injection of 0,5% levobupivacaine. and Intraperitoneal atomization of levobupivacaine. in people with Pain, Postoperative, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) . Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Standard Injection of Levobupivacaine in portal sites., Additional injection of 0,5% levobupivacaine. and Intraperitoneal atomization of levobupivacaine.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 26 Jun 2013to 3 Dec 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are planned for gynaecological laparoscopic interventions on an ambulatory basis.
Who cannot join
- Less than 18 year old.
- Weight less than 50 kg and more than 80 kg.
- Pregnant.
- Prisoners;
- Allergic to topical anesthetics (Amides specifically).
- Allergic to Opioids as a class.
- Currently or within the last 30 days been prescribed an opiate medication.
- Chronic pain syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery . The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray device, an inexpensive delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).
Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain and of opioid requirements in patients undergoing gynecological laparoscopic procedures in one-day surgery.
- Conditions
- Pain, Postoperative
- Being tested
- Standard Injection of Levobupivacaine in portal sites., Additional injection of 0,5% levobupivacaine., Intraperitoneal atomization of levobupivacaine.
- Keywords
- laparoscopic, pain
- 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.
Standard Injection of Levobupivacaine in portal sites.Drug
All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal.
Additional injection of 0,5% levobupivacaine.Drug
Immediately following insufflation 0.15ml/kg levobupivacaine will be injected in the peritoneal cavity via a trocar. At the end of the surgery, this process will be repeated with the same dose at 0.15ml/kg.
Intraperitoneal atomization of levobupivacaine.Drug
Immediately following insufflation the Optispray® surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes:
- Each subdiaphragmatic area 0.05 ml/kg
- Dome of abdomen then settling onto bowel 0.05 ml/kg
- Surgical dissection site 0.05 ml/kg
- At the end of the surgery - this process will be repeated with the same doses at 0.15 ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Infiltration of portal sites with 0,5% levobupivacaine. | Active comparator | The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine). Receives: Drug: Standard Injection of Levobupivacaine in portal sites. |
| Additional injection of 0.5% levobupivacaine via a trocar | Experimental | The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery. Receives: Drug: Standard Injection of Levobupivacaine in portal sites.; Drug: Additional injection of 0,5% levobupivacaine. |
| Additional intraperitoneal atomization of levobupivacaine. | Experimental | The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. Receives: Drug: Standard Injection of Levobupivacaine in portal sites.; Drug: Intraperitoneal atomization of levobupivacaine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Secondary outcomes (7)
Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.
Piritramide 0,05 mg/kg
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.
Patients will be asked to evaluate their pain at 6 hrs, 12 hrs, 18 hrs and 24 hrs post-operatively using an 11-point numeric rating scale (0=no pain and 10= worse pain possible) and report it by telephone.
Measured: Patients will be followed until 24 hours post-operatively.
Post-operative shoulder pain after laparoscopic gynecological surgery from hospital discharge until 24 hrs post-operatively.
Patients will be asked to evaluate their pain at 6 hrs, 12 hrs, 18 hrs and 24 hrs post-operatively using an 11-point numeric rating scale (0=no pain and 10= worse pain possible) and report it by telephone.
Measured: Patients will be followed until 24 hours post-operatively.
Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.
Nausea and vomiting will be evaluated every 15' during the first 2 hrs, every 30' until hospital discharge, using a PONV verbal descriptor scale 0 to 2 points : 0=no nausea, 1=any nausea, 2 =vomiting. After discharge, patients wil be asked to evaluate PONV at 6 hrs, 12 hrs, 18 hrs and 24 hrs post-operatively and report it by telephone.
Measured: Patients will be followed until 24 hours post-operatively.
Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.
Sedation will be evaluated at 0, 1, 2, 4, 6 hrs post-operatively, using the Ramsay sedation score (1= anxious and agitated, 2= cooperative, tranquil, oriented, 3=responds only to verbal commands, 4= asleep with brisk response to light stimulation, 5=asleep without response to light stimulation, 6=non-responsive).
Measured: Patients will be followed up to 6 hrs post-operatively.
Time until discharge from recovery room.
Discharge criterion: aldrete ≥ 9/10.
Measured: Up until discharge from recovery room post-operatively, probably a few hours.
Time until discharge from hospital.
Discharge criterion : modified aldrete ≥ 12/14.
Measured: Patients will be followed until an estimated 24 hours post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start26 Jun 2013
- Primary completion13 Jun 2014
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Coppens, mD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886352
- Sponsor's protocol ID
- 2013/089
- Acronym
- IPLA
- Status last verified
- Dec 2018
- First submitted
- 7 Jun 2013
- Last updated
- 5 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
- ClinicalTrials.gov ID
- NCT01886352
- Acronym / sponsor ID
- IPLA / 2013/089
- Conditions
- Pain, Postoperative
- Keywords
- laparoscopic, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 26 Jun 2013 (actual)
- Primary completion
- 13 Jun 2014 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 25 Jun 2013 (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.
In this study, we will compare 3 treatments. The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) . The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery . The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. We will use non-diluted 0.5% levobupivacaine delivered directly onto the target sites both at the beginning and the end of surgery. The drug will be delivered using OptiSpray® surgical spray device, an inexpensive delivery system that will direct a fine mist of drug directly to the areas of the peritoneal cavity that are theoretically the cause of post-op pain (diaphragms, peritoneal abdominal surface, surgical dissection site).
Our primary goal is to assess the efficacy of intraperitoneal atomization of levobupivacaine in reducing postoperative pain and of opioid requirements in patients undergoing gynecological laparoscopic procedures in one-day surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infiltration of portal sites with 0,5% levobupivacaine. | Active comparator | Drug: Standard Injection of Levobupivacaine in portal sites.The first group of patients will receive the standard treatment (paracetamol, diclofenac and an opioid if necessary) with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine). |
| Additional injection of 0.5% levobupivacaine via a trocar | Experimental | Drug: Standard Injection of Levobupivacaine in portal sites., Drug: Additional injection of 0,5% levobupivacaine.The second group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional injection of the local anesthetic ( 0.5% levobupivacaine, non -diluted) in the peritoneal cavity via a trocar both at the beginning and the end of the surgery. |
| Additional intraperitoneal atomization of levobupivacaine. | Experimental | Drug: Standard Injection of Levobupivacaine in portal sites., Drug: Intraperitoneal atomization of levobupivacaine.The third group of patients will receive the standard of care, with infiltration of the portal sites with the local anesthetic ( 0.5% levobupivacaine) and additional intraperitoneal atomization of the local anesthetic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are planned for gynaecological laparoscopic interventions on an ambulatory basis.
Key exclusion criteria (8 listed)
- Less than 18 year old.
- Weight less than 50 kg and more than 80 kg.
- Pregnant.
- Prisoners;
- Allergic to topical anesthetics (Amides specifically).
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 |
|---|---|---|
| Standard Injection of Levobupivacaine in portal sites.All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal. | Drug | Additional injection of 0.5% levobupivacaine via a trocar, Additional intraperitoneal atomization of levobupivacaine., Infiltration of portal sites with 0,5% levobupivacaine. |
| Additional injection of 0,5% levobupivacaine.Immediately following insufflation 0.15ml/kg levobupivacaine will be injected in the peritoneal cavity via a trocar. At the end of the surgery, this process will be repeated with the same dose at 0.15ml/kg. | Drug | Additional injection of 0.5% levobupivacaine via a trocar |
| Intraperitoneal atomization of levobupivacaine.Immediately following insufflation the Optispray® surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes: 1. Each subdiaphragmatic area 0.05 ml/kg 2. Dome of abdomen then settling onto bowel 0.05 ml/kg 3. Surgical dissection site 0.05 ml/kg 4. At the end of the surgery - this process will be repeated with the same doses at 0.15 ml/kg. | Drug | Additional intraperitoneal atomization of levobupivacaine. |
Primary outcome
Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).
7 secondary outcomes
Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.
Time frame: Patients will be followed until 24 hours post-operatively.
Post-operative shoulder pain after laparoscopic gynecological surgery from hospital discharge until 24 hrs post-operatively.
Time frame: Patients will be followed until 24 hours post-operatively.
Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.
Time frame: Patients will be followed until 24 hours post-operatively.
Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.
Time frame: Patients will be followed up to 6 hrs post-operatively.
Time until discharge from recovery room.
Time frame: Up until discharge from recovery room post-operatively, probably a few hours.
Time until discharge from hospital.
Time frame: Patients will be followed until an estimated 24 hours post-operatively.
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 Dec 2018.
- Related InfoLink provided by the sponsor.
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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.
Marc Coppens, mD principal investigator
University Hospital, Ghent
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 Standard Injection of Levobupivacaine in portal sites., Additional injection of 0,5% levobupivacaine. and Intraperitoneal atomization of levobupivacaine. in people with Pain, Postoperative, run by University Hospital, Ghent at 1 site in Belgium.
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 8 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 Dec 2018. 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 Belgium. 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 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?
Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting. (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.). 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 5 Dec 2018.