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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 4

Conditions: Pain, Postoperative

Treatments: Drug: Standard Injection of Levobupivacaine in portal sites.; Drug: Intraperitoneal atomization of levobupivacaine.; Drug: Additional injection of 0,5% levobupivacaine.

Study type: Interventional

Funder types: Other

Identifiers

NCT01886352

2013/089

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 3 patient groups

Infiltration of portal sites with 0,5% levobupivacaine.

Active Comparator group

Description:

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).

Treatment:

Drug: Standard Injection of Levobupivacaine in portal sites.

Additional injection of 0.5% levobupivacaine via a trocar

Experimental group

Description:

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.

Treatment:

Drug: Additional injection of 0,5% levobupivacaine.

Drug: Standard Injection of Levobupivacaine in portal sites.

Additional intraperitoneal atomization of levobupivacaine.

Experimental group

Description:

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.

Treatment:

Drug: Intraperitoneal atomization of levobupivacaine.

Drug: Standard Injection of Levobupivacaine in portal sites.