Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000727943
Ethics application status
Approved
Date submitted
27/06/2011
Date registered
12/07/2011
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
TAP Block Study - A Prospective, Double-blind Randomised Trial to Assess the Efficacy of Ultrasound Guided Transversus Abdominis Plane Blocks Using Ropivacaine in Patients Undergoing Laparoscopic Abdominal Surgery.
Scientific title
A Prospective, Double-blind Randomised Trial to Assess the Efficacy of Ultrasound Guided Transversus Abdominis Plane (TAP) Blocks Using Ropivacaine in Patients Undergoing Laparoscopic Abdominal Surgery.
Secondary ID [1] 262335 0
Nil
Universal Trial Number (UTN)
Trial acronym
Transversus Abdominis Plane (TAP) Block
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative pain 268038 0
Condition category
Condition code
Anaesthesiology 268169 268169 0 0
Pain management
Surgery 268303 268303 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients enrolled in the study who are undergoing elective abdominal laparoscopic surgery.
Intervention Procedure: A is ultrasound (US)-Guided single dose injection of local anaesthetic agent Ropivacaine (injected between the muscle layers in the abdomen after general anaesthesia has begun), with dose based on patient weight. Subjects will also receive Patient-Controlled Analgesia with Morphine (1mg per dose with 5 minute lockout) or Fentanyl (10mcg per dose with 5 minute lockout) administered intravenously at the discretion of the anaesthetist. Subjects allocated to the control group will receive Patient-Controlled Analgesia only. In both treatment groups the Patient-Controlled Analgesia will be administered for up to 4 days post-surgery or until no longer required.
Intervention code [1] 266724 0
Other interventions
Intervention code [2] 266949 0
Treatment: Drugs
Comparator / control treatment
Patient-Controlled Analgesia with Morphine (1mg per dose with 5 minute lockout) or Fentanyl (10mcg per dose with 5 minute lockout) administered intravenously, commencing whilst in recovery and continuing for up to 4 days after surgery.
Control group
Active

Outcomes
Primary outcome [1] 269183 0
mg/kg of morphine equivalent used by patients post operatively.
Timepoint [1] 269183 0
from operation until discharge from hospital narcotic use will be reviewed by examing patient-controlled analgesia infusion pumps to examine doses given per hour.
Secondary outcome [1] 279083 0
Lung Function (spirometry), including forced vital capacity (FVC), Forced Expiratory Volume (FEV1) and Peak Expiratory Flow Rate (PEFR)
Timepoint [1] 279083 0
24, 48 and 72 hours postoperatively.
Secondary outcome [2] 279084 0
Pain score as measured by a Visual Analogue Scale (VAS) for pain at rest, deep breathing and coughing
Timepoint [2] 279084 0
24, 48 and 72 hours postoperatively

Eligibility
Key inclusion criteria
All patients undergoing elective laparoscopic abdominal surgery by the three participating surgeons
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Refuse or are unable to give written informed consent to participate in the study, or
-receive an epidural anaesthetic or other loco-regional anaesthesia, or
-are under 18 years of age, or
-have severe renal impairment
-receive an operation that involved incisions outside the abdominal wall (such as abdomino-perineal resections) or
-have a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or
have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a computer generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/06/2011
Actual
15/07/2011
Date of last participant enrolment
Anticipated
Actual
18/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
142
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267210 0
Self funded/Unfunded
Name [1] 267210 0
Country [1] 267210 0
Australia
Primary sponsor type
Hospital
Name
John Hunter Hospital
Address
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country
Australia
Secondary sponsor category [1] 266279 0
Hospital
Name [1] 266279 0
Newcastle Private Hospital
Address [1] 266279 0
Lookout Road
New lambton Heights NSW 2305
Country [1] 266279 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269203 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 269203 0
Ethics committee country [1] 269203 0
Australia
Date submitted for ethics approval [1] 269203 0
Approval date [1] 269203 0
25/05/2011
Ethics approval number [1] 269203 0
11/04/20/3.04

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32713 0
Dr Stephen Smith
Address 32713 0
Newcastle Private Consultation Suites
Suite G7
Lookout Road New Lambton Heights NSW 2305
Country 32713 0
Australia
Phone 32713 0
+61 2 49563243
Fax 32713 0
Email 32713 0
stephen.smith@hnehealth.nsw.gov.au
Contact person for public queries
Name 15960 0
Rosemary Carroll
Address 15960 0
Division of Surgery
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre NSW 2310
Country 15960 0
Australia
Phone 15960 0
+61 2 49855153
Fax 15960 0
Email 15960 0
rosemary.carroll@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 6888 0
Stephen Smith
Address 6888 0
Newcastle Private Consultation Suites
Suite G7
Lookout Road
New Lambton Heights NSW 2305
Country 6888 0
Australia
Phone 6888 0
+61 2 49563243
Fax 6888 0
Email 6888 0
stephen.smith@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.