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

This study has been completed.
Sponsor:
Collaborator:
Department of Surgery
Information provided by (Responsible Party):
Jens Borglum Neimann, Bispebjerg Hospital
ClinicalTrials.gov Identifier:
NCT01825863
First received: March 27, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Appendicitis
Drug: Ropivacaine
Drug: Saline 9%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Postoperative Pain Management by Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis - a Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Bispebjerg Hospital:

Primary Outcome Measures:
  • Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10 [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]
    Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.


Secondary Outcome Measures:
  • Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10 [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]
    NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.

  • Morphine consumption postoperatively [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]
    Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.

  • Length of stay (LOS) in the postanesthesia care unit (PACU) [ Time Frame: Time from arrival in PACU to time of departure (measured in minutes) ] [ Designated as safety issue: No ]
  • Side effects related to morphine consumption [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]
    Side effects recorded: nausea and vomiting

  • Time to first mobilisation 0-12 hours postoperatively [ Time Frame: 0-12 hours postoperatively ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active abdominal wall block
60ml ropivacaine 0.375% single shot
Drug: Ropivacaine
Placebo Comparator: Placebo abdominal wall block
60ml saline 9% single shot
Drug: Saline 9%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01825863

Locations
Denmark
Department of anaesthesiology, Bispebjerg Hospital
Copenhagen, Denmark, 2400 NV
Sponsors and Collaborators
Bispebjerg Hospital
Department of Surgery
Investigators
Principal Investigator: Katrine Tanggaard, research year fellow Bispebjerg Hospital
  More Information

Publications:
Responsible Party: Jens Borglum Neimann, Associate professor, consultant anesthetist, PhD, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01825863     History of Changes
Other Study ID Numbers: BBH-BDTAP-APP
Study First Received: March 27, 2013
Last Updated: January 16, 2014
Health Authority: Denmark: The GCP unit at University of Copenhagen, Bispebjerg Hospital, Bygning 51, 3.sal, Bispebjerg Bakke 23, 2400 Copenhagen NV, Denmark

Keywords provided by Bispebjerg Hospital:
Laparoscopy
Adult
Nerve block
Ultrasonography

Additional relevant MeSH terms:
Appendicitis
Acute Disease
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 08, 2014