Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.

Study Overview
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Brief Summary
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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.

Official Title
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Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.

Conditions
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Appendicitis

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Saline 9%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active abdominal wall block<br>60ml ropivacaine 0.375% single shot | Drug: Ropivacaine<br> <br> |
| Placebo Comparator: Placebo abdominal wall block<br>60ml saline 9% single shot | Drug: Saline 9%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10 | Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours. | 0-12 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10 | NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively. | 0-12 hours postoperatively | 
| Morphine consumption postoperatively | Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump. | 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 | Side effects recorded: nausea and vomiting | 0-12 hours postoperatively | 
| Time to first mobilisation 0-12 hours postoperatively |  | 0-12 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopy, Adult, Nerve block, Ultrasonography