Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).

NCT ID: NCT01886352

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-26
• Study Completion Date: 2018-12-03

Brief 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) . 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infiltration of portal sites with 0,5% levobupivacaine.

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).

Group Type: ACTIVE_COMPARATOR

Standard Injection of Levobupivacaine in portal sites.

Intervention Type: 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 via a trocar

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.

Group Type: EXPERIMENTAL

Standard Injection of Levobupivacaine in portal sites.

Intervention Type: 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.

Intervention Type: 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.

Additional 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.

Group Type: EXPERIMENTAL

Standard Injection of Levobupivacaine in portal sites.

Intervention Type: DRUG

All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal.

Intraperitoneal atomization of levobupivacaine.

Intervention Type: 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:

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who are planned for gynaecological laparoscopic interventions on an ambulatory basis.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Coppens, mD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

Ghent University Hospital

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

Related Info

Other Identifiers

2013/089

Identifier Type: -

Identifier Source: org_study_id