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

NCT01886352 | Completed Phase 4

• 1 other identifier: 2013/089
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

laparoscopic; pain

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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.

  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 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 followed until 24 hours post-operatively.

• Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery.

  Patients will be followed until 24 hours post-operatively.

• Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery.

  Patients will be followed up to 6 hrs post-operatively.

Study Arms (3)

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).

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.

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.

Drug: Standard Injection of Levobupivacaine in portal sites.; Drug: Intraperitoneal atomization of levobupivacaine.

Interventions

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 via a trocar; Additional intraperitoneal atomization of levobupivacaine.; Infiltration of portal sites with 0,5% levobupivacaine.

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.

Additional injection of 0.5% levobupivacaine via a trocar

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: 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.

Additional intraperitoneal atomization of levobupivacaine.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Marc Coppens, mD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 25, 2013
• Study Start: June 26, 2013
• Primary Completion: June 13, 2014
• Study Completion: December 3, 2018
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

BE (1)