Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis. (BD-TAP APP)

Bispebjerg Hospital

Status: Completed

Conditions: Appendicitis

Treatments: Drug: Ropivacaine; Drug: Saline 9%

Study type: Interventional

Funder types: Other

Identifiers

NCT01825863

BBH-BDTAP-APP

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

56 participants in 2 patient groups, including a placebo group

Active abdominal wall block

Active Comparator group

Description:

60ml ropivacaine 0.375% single shot

Treatment:

Drug: Ropivacaine

Placebo abdominal wall block

Placebo Comparator group

Description:

60ml saline 9% single shot

Treatment:

Drug: Saline 9%