To analyse the effect of preoperative intracutaneous and intraperitoneal instillation of levobupivacaine on postoperative pain after laparoscopic cholecystectomy
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative Visual Analogue Score is conducted just before the procedure and
afterwards at 30 min, 2h, 4h, 8h, and 24 hours, split in shoulder pain and
abdominal pain. The abdominal/shoulder pain scores will also be split in rest,
cough and movement pain
Secondary outcome
- Rescue analgesia treatment. Rescue analgesia will be given when the pain
score (VAS) rises above 40.
- Adverse events caused by the investigational procedure or by levobupivacaine
itself.
- Length of the surgical procedure
- Length of hospital stay
- Time to resumption of work or other usual daily activities
- Development of postoperative complications during hospitalisation including
pneumonia, thrombosis, urinary tract infections, wound abscess and bile leakage.
- Development of intraoperative complications including perforation of the
gallbladder, bile duct injury, bowel injury and injury to vascular structures.
- The presence of persistent postoperative pain after three
months
Background summary
Laparoscopic surgery is associated with fewer complications, reduced
post-operative pain, reduced length of hospitalisation and less use of
analgesia. However, abdominal pain and shoulder pain are still very common side
effects associated with laparoscopy. To further reduce postoperative pain, long
acting local anaesthetics are a promising solution. These local anaesthetics
can be used for trocar- and port-site wound infiltration to prevent abdominal
pain and for intraperitoneal instillation and visceral infiltration to reduce
deep abdominal pain and referred shoulder pain.
Two long acting local anaesthetics are favourable for a long lasting
nerve block; levobupivacaine (chirocaine®) and ropivacaine (naropin®), mainly
because of their low toxic profile. However, there is lack of evidence whether
levobupivacaine, administrated preoperatively intracutaneous and
intraperitoneally, gives significant pain reduction.
Therefore we constructed a randomised study to investigate if
preoperative local and intraperitoneal instillation of levobupivacaine reduces
postoperative pain and thus length of hospitalisation and use of analgesics in
patients who undergo elective laparoscopic cholecystectomies for symptomatic
gallstone disease compared to a normal saline control group.
Study objective
To analyse the effect of preoperative intracutaneous and intraperitoneal
instillation of levobupivacaine on postoperative pain after laparoscopic
cholecystectomy
Study design
Prospective, randomised double blinded clinical trial. Experiment group n = 40
and a placebo group n = 40. Total n = 80.
Intervention
A total of 20 mL (1,25 mg/mL levobupivacaine or normal saline) is administered
subcutaneously at all trocar sites before surgery. In addition, 60 mL (1,25
mg/mL LB or saline) is administered in the intraperitoneal cavity at the site
of the gallbladder and right hemidiaphragm after creation of the
pneumoperitoneum and placement of trocars
Study burden and risks
The burden for the patient is being questioned six times. The most severe risk
is a convulsion caused by accidentally administrating the local anaesthetic
intravascular, thereby inducing an overdose. Another rare risk may include an
allergic reaction to the amid-type local anaesthetic.
The potential value of this study is a significant post operative pain
reduction after laparoscopic cholecystectomy, which may be translated to other
laparoscopic procedures. The advantage of pain reduction is a lower perceived
burden for the patient, shorter hospitalization and a faster recovery.
Moreover, the postoperative use of analgesics may be reduced.
Utrechtseweg 160
3818 ES Amersfoort
NL
Utrechtseweg 160
3818 ES Amersfoort
NL
Listed location countries
Age
Inclusion criteria
The patients who will be included are 18-75 of age and ASA I&II, which means that no or mild systemic disease is present according to the classification system of the American Society of Anaesthesiologists. The patients are included when a surgeon sets the indication for a laparoscopic cholecystectomy. The indication is symptomatic gallstone disease. If the laparoscopic cholecystectomy transfers to an open procedure, the patients will receive an equal follow up (intention-to-treat principle).
Exclusion criteria
- Patients with cholecystitis, septic shock from cholangitis, severe acute pancreatitis, advanced cirrhosis, and gallbladder cancer
- Patients with a medical history of epilepsy, cardiac arrhytmias or chronical pain of any kind .
- If a patient is allergic to drugs of the amid type.
- Pregnancy
- Subject suffering from hypotension or hypovolemia.
- Subjects suffering from liver disease
- Subject using drugs which deduce function of the CYP3A4 system like ketoconazol.
-Subject using drugs which deduce function of the CYP1A2 system like the methylxanthines(Fluvoxamin enoxacin)
- Patients with conditions making them incapable of filling out the questionnaires.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2009-012639-13-NL |
| CCMO | NL28180.100.09 |