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

NCT01825863 | Completed DMC

• 1 other identifier: BBH-BDTAP-APP
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Appendicitis

Keywords

Laparoscopy; Adult; Nerve block; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

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

  0-12 hours postoperatively

• Morphine consumption postoperatively

  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

  0-12 hours postoperatively

• Time to first mobilisation 0-12 hours postoperatively

  0-12 hours postoperatively

Study Arms (2)

Active abdominal wall block

ACTIVE COMPARATOR

60ml ropivacaine 0.375% single shot

Drug: Ropivacaine

Placebo abdominal wall block

PLACEBO COMPARATOR

60ml saline 9% single shot

Drug: Saline 9%

Interventions

Ropivacaine DRUG

Active abdominal wall block

Saline 9% DRUG

Placebo abdominal wall block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Department of anaesthesiology, Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

Location

Related Publications (1)

• 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.

  PMID: 22476239 BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Katrine Tanggaard, research year fellow

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, consultant anesthetist, PhD

Study Record Dates

• First Submitted: March 27, 2013
• First Posted: April 8, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 22, 2015

Record last verified: 2015-07

Locations

DK (1)