Clinical trial NCT01886352: Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
Official title: Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Keywords: laparoscopic
pain
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Post-operative pain intensity after laparoscopic gynaecological surgery in 1-day hospital setting.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
measure: Post-operative shoulder pain after laparoscopic gynecological procedure in 1-day hospital setting.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Secondary outcomes:
measure: Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
measure: Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs post-operatively.
timeFrame: Patients will be followed until 24 hours post-operatively.
measure: Post-operative shoulder pain after laparoscopic gynecological surgery from hospital discharge until 24 hrs post-operatively.
timeFrame: Patients will be followed until 24 hours post-operatively.
measure: Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.
timeFrame: Patients will be followed until 24 hours post-operatively.
measure: Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.
timeFrame: Patients will be followed up to 6 hrs post-operatively.
measure: Time until discharge from recovery room.
timeFrame: Up until discharge from recovery room post-operatively, probably a few hours.
measure: Time until discharge from hospital.
timeFrame: Patients will be followed until an estimated 24 hours post-operatively.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Marc Coppens, mD
role: PRINCIPAL_INVESTIGATOR
References: