Skip to main content
OpenTrials
Completed

NCT Number: NCT01886352

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ghent University Hospital

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

    Piritramide 0,05 mg/kg

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

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

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

    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).

  6. Time until discharge from recovery room.

    Time frame: Up until discharge from recovery room post-operatively, probably a few hours.

    Discharge criterion: aldrete ≥ 9/10.

  7. Time until discharge from hospital.

    Time frame: Patients will be followed until an estimated 24 hours post-operatively.

    Discharge criterion : modified aldrete ≥ 12/14.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Acronym: IPLA

Important dates

Study start
2013
Primary completion
2014
Study completion
2018
First posted
Jun 25, 2013
Registry last updated
Dec 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.