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

NCT ID: NCT01825863

Last Updated: 2015-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active abdominal wall block

60ml ropivacaine 0.375% single shot

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Placebo abdominal wall block

60ml saline 9% single shot

Group Type PLACEBO_COMPARATOR

Saline 9%

Intervention Type DRUG

Interventions

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Ropivacaine

Intervention Type DRUG

Saline 9%

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jens Borglum Neimann

Associate professor, consultant anesthetist, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katrine Tanggaard, research year fellow

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Department of anaesthesiology, Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 22476239 (View on PubMed)

Other Identifiers

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BBH-BDTAP-APP

Identifier Type: -

Identifier Source: org_study_id

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