Pain, Postoperative Clinical Trial
— IPLAOfficial title:
Intraperitoneal Atomization of Levobupivacaine During Gynaecological Laparoscopic Procedures ; Impact on Pain, Opioid Use and Length of Recovery Room Stay (IPLA).
Verified date | December 2018 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | December 3, 2018 |
Est. primary completion date | June 13, 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Ghent University Hospital | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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 | Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery. | Piritramide 0,05 mg/kg | Participants will be followed for the duration of hospital stay, an expected average of 1 day. | |
Secondary | Post-operative pain intensity after laparoscopic gynaecological surgery from hospital discharge until 24 hrs 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. | Patients will be followed until 24 hours post-operatively. | |
Secondary | Post-operative shoulder pain after laparoscopic gynecological surgery from hospital discharge until 24 hrs 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. | Patients will be followed until 24 hours post-operatively. | |
Secondary | Post-operative nausea and vomiting (PONV) in the first 24 hrs post-operatively, after laparoscopic gynecological surgery. | 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. | Patients will be followed until 24 hours post-operatively. | |
Secondary | Post-operative sedation until hospital discharge, after laparoscopic gynecological surgery. | 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). | Patients will be followed up to 6 hrs post-operatively. | |
Secondary | Time until discharge from recovery room. | Discharge criterion: aldrete = 9/10. | Up until discharge from recovery room post-operatively, probably a few hours. | |
Secondary | Time until discharge from hospital. | Discharge criterion : modified aldrete = 12/14. | Patients will be followed until an estimated 24 hours post-operatively. |
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