Clinical trial NCT01825863: Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.
Official title: Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Keywords: Laparoscopy
Adult
Nerve block
Ultrasonography
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Age above 18 years
* Patients undergoing diagnostic laparoscopy for acute appendicitis
* American Society of Anaesthesiology group 1-3
* General Anaesthesia

Exclusion Criteria:

* Inability to cooperate
* Inability to understand and talk danish
* Allergic to ropivacaine
* Drug and alcohol abuse
* Pregnancy or nursing

Primary outcomes:
measure: Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10
timeFrame: 0-12 hours postoperatively
Secondary outcomes:
measure: Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10
timeFrame: 0-12 hours postoperatively
measure: Morphine consumption postoperatively
timeFrame: 0-12 hours postoperatively
measure: Length of stay (LOS) in the postanesthesia care unit (PACU)
timeFrame: Time from arrival in PACU to time of departure (measured in minutes)
measure: Side effects related to morphine consumption
timeFrame: 0-12 hours postoperatively
measure: Time to first mobilisation 0-12 hours postoperatively
timeFrame: 0-12 hours postoperatively
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesiology, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Katrine Tanggaard, research year fellow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.