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Completed

NCT Number: NCT01825863

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of anaesthesiology, Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

Saline 9%

Drug

Primary outcomes

  1. Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10

    Time frame: 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 outcomes

  1. Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10

    Time frame: 0-12 hours postoperatively

    NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.

  2. Morphine consumption postoperatively

    Time frame: 0-12 hours postoperatively

    Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.

  3. Length of stay (LOS) in the postanesthesia care unit (PACU)

    Time frame: Time from arrival in PACU to time of departure (measured in minutes)

  4. Side effects related to morphine consumption

    Time frame: 0-12 hours postoperatively

    Side effects recorded: nausea and vomiting

  5. Time to first mobilisation 0-12 hours postoperatively

    Time frame: 0-12 hours postoperatively

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: BD-TAP APP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 8, 2013
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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