A Phase 4 interventional study of Standard Injection of Levobupivacaine in portal sites. and Additional injection of 0,5% levobupivacaine. in Pain, Postoperative, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-05.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 16 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
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.
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.
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.
All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal.
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.
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.
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).
Time frame: 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).
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day.
Post-operative opioid analgesic requirements after laparoscopic gynaecological surgery.
Piritramide 0,05 mg/kg
Time frame: 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 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.
Time frame: 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 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.
Time frame: 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.
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.
Time frame: Patients will be followed until 24 hours post-operatively.
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).
Time frame: Patients will be followed up to 6 hrs post-operatively.
Time until discharge from recovery room.
Discharge criterion: aldrete ≥ 9/10.
Time frame: Up until discharge from recovery room post-operatively, probably a few hours.
Time until discharge from hospital.
Discharge criterion : modified aldrete ≥ 12/14.
Time frame: Patients will be followed until an estimated 24 hours post-operatively.
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University Hospital, Ghent