Trial record 5 of 1331 for:    gynecology

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01886352
First received: June 7, 2013
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Post-operative Pain After Laparoscopic One-day Surgery.
Drug: Standard Injection of Levobupivacaine in portal sites.
Drug: Additional injection of 0,5% levobupivacaine.
Drug: Intraperitoneal atomization of levobupivacaine.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).

  • 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. ] [ Designated as safety issue: No ]
    Pain evaluation will be done using an 11-point numeric rating scale (0 = no pain, 10 = worst pain possible).


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Piritramide 0,05 mg/kg

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • 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. ] [ Designated as safety issue: No ]
    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.

  • Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery. [ Time Frame: Patients will be followed up to 6 hrs post-operatively. ] [ Designated as safety issue: No ]
    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).

  • Time until discharge from recovery room. [ Time Frame: Up until discharge from recovery room post-operatively, probably a few hours. ] [ Designated as safety issue: No ]
    Discharge criterion: aldrete ≥ 9/10.

  • Time until discharge from hospital. [ Time Frame: Patients will be followed until an estimated 24 hours post-operatively. ] [ Designated as safety issue: No ]
    Discharge criterion : modified aldrete ≥ 12/14.


Estimated Enrollment: 60
Study Start Date: June 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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).
Drug: 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.
Experimental: 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.
Drug: 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.
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.
Experimental: 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.
Drug: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01886352

Contacts
Contact: Marc Coppens, MD Marc.Coppens@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Marc Coppens, MD       Marc.Coppens@ugent.be   
Principal Investigator: Marc Coppens, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Marc Coppens, mD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01886352     History of Changes
Other Study ID Numbers: 2013/089
Study First Received: June 7, 2013
Last Updated: June 21, 2013
Health Authority: Belgium: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:
laparoscopic
pain

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics, Opioid
Levobupivacaine
Bupivacaine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on August 20, 2014