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

Appendicitis Clinical Trial

— BD-TAP APP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01825863
• Other study ID #: BBH-BDTAP-APP
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: July 20, 2015
• Start date: June 2013
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The GCP unit at University of Copenhagen, Bispebjerg Hospital, Bygning 51, 3.sal, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Appendicitis

Intervention

Drug:
• Ropivacaine

• Saline 9%

Locations

Country	Name	City	State
Denmark	Department of anaesthesiology, Bispebjerg Hospital	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Børglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lönnqvist 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Morphine consumption postoperatively	Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.	0-12 hours postoperatively	No
Secondary	Length of stay (LOS) in the postanesthesia care unit (PACU)		Time from arrival in PACU to time of departure (measured in minutes)	No
Secondary	Side effects related to morphine consumption	Side effects recorded: nausea and vomiting	0-12 hours postoperatively	No
Secondary	Time to first mobilisation 0-12 hours postoperatively		0-12 hours postoperatively	No