Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis. (BD-TAP APP)
Primary Purpose
Appendicitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Ropivacaine
Saline 9%
Sponsored by
About this trial
This is an interventional treatment trial for Appendicitis focused on measuring Laparoscopy, Adult, Nerve block, Ultrasonography
Eligibility 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
Sites / Locations
- Department of anaesthesiology, Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active abdominal wall block
Placebo abdominal wall block
Arm Description
60ml ropivacaine 0.375% single shot
60ml saline 9% single shot
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Morphine consumption postoperatively
Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.
Length of stay (LOS) in the postanesthesia care unit (PACU)
Side effects related to morphine consumption
Side effects recorded: nausea and vomiting
Time to first mobilisation 0-12 hours postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01825863
Brief Title
Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis
Keywords
Laparoscopy, Adult, Nerve block, Ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active abdominal wall block
Arm Type
Active Comparator
Arm Description
60ml ropivacaine 0.375% single shot
Arm Title
Placebo abdominal wall block
Arm Type
Placebo Comparator
Arm Description
60ml saline 9% single shot
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Type
Drug
Intervention Name(s)
Saline 9%
Primary Outcome Measure Information:
Title
Area under the curve (AUC), 0-12 hours, numerical rating score-pain-(NRS)0-10
Description
Pain score (NRS) assessed when sitting up 0-12 hours postoperatively. AUC is calculated over a time frame of 0-12 hours.
Time Frame
0-12 hours postoperatively
Secondary Outcome Measure Information:
Title
Area under the curve (AUC), 0-12 hours postoperatively, numerical rating score - pain-(NRS) 0-10
Description
NRS 0-10 is assessed 0-12 hours postoperatively. AUC is calculated 0-12 hours postoperatively.
Time Frame
0-12 hours postoperatively
Title
Morphine consumption postoperatively
Description
Morphine consumption postoperatively registered from the patient controlled analgesia (PCA) pump.
Time Frame
0-12 hours postoperatively
Title
Length of stay (LOS) in the postanesthesia care unit (PACU)
Time Frame
Time from arrival in PACU to time of departure (measured in minutes)
Title
Side effects related to morphine consumption
Description
Side effects recorded: nausea and vomiting
Time Frame
0-12 hours postoperatively
Title
Time to first mobilisation 0-12 hours postoperatively
Time Frame
0-12 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrine Tanggaard, research year fellow
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of anaesthesiology, Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400 NV
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
22476239
Citation
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.
Results Reference
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Ultrasound-guided Abdominal Wall Nerve Blockade in Laparoscopic Surgery for Acute Appendicitis.
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