Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.
- Registration Number
- NCT01825863
- Lead Sponsor
- Bispebjerg Hospital
- Brief Summary
Acute appendicitis is a common disease and usually occurs within the ages of 10-30 years old." Ten percent of the population will get this disease during a lifetime." At Bispebjerg hospital it is one of the most common acute surgeries performed. Though at Bispebjerg hospital the surgery is only performed on adults as there is no pediatric ward. The surgical technique is primarily laparoscopic surgery, where the patients have their appendix removed while in general anaesthesia. During the last three years Bispebjerg hospital has had an average of 287 patients per year undergoing laparoscopic surgery. From January to the September 2012 a total of 211 patients have had the operation, with 29% having the operation performed during daytime, 48% in the evening and 22% at night. Open appendectomy is only performed in cases where laparoscopic surgery is impossible, this is often due to adhesions, scar tissue from former abdominal surgery or peritonitis. The scars from laparoscopic surgery are usually smaller than that from an open appendectomy, but it gives the patient three smaller scars divided on three abdominal quadrants instead of one larger scar on one quadrant.
The investigators want to conduct a clinical trial with fifty six patients undergoing laparoscopic surgery due to acute appendicitis. The investigators want to find out if it is possible to improve the post-operative pain management within this very large group of patients undergoing acute surgery. In detail, the investigators wish to explore whether the use of the BD-TAP blockade in the abdominal wall on patients undergoing laparoscopic surgery due to acute appendicitis, can anesthetize the patients completely or partially, so they can avoid morphine intake completely or partially during the post-operative phase (12-24 hours). The research project will be a randomized, double-blinded, controlled clinical trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- Age above 18 years
- Patients undergoing diagnostic laparoscopy for acute appendicitis
- American Society of Anaesthesiology group 1-3
- General Anaesthesia
- Inability to cooperate
- Inability to understand and talk danish
- Allergic to ropivacaine
- Drug and alcohol abuse
- Pregnancy or nursing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo abdominal wall block Saline 9% 60ml saline 9% single shot Active abdominal wall block Ropivacaine 60ml ropivacaine 0.375% single shot
- Primary Outcome Measures
Name Time Method Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10 0-12 hours postoperatively Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.
- Secondary Outcome Measures
Name Time Method Morphine consumption postoperatively 0-12 hours postoperatively Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.
Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10 0-12 hours postoperatively NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.
Length of stay (LOS) in the postanesthesia care unit (PACU) Time from arrival in PACU to time of departure (measured in minutes) Side effects related to morphine consumption 0-12 hours postoperatively Side effects recorded: nausea and vomiting
Time to first mobilisation 0-12 hours postoperatively 0-12 hours postoperatively
Trial Locations
- Locations (1)
Department of anaesthesiology, Bispebjerg Hospital
🇩🇰Copenhagen, Denmark