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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00682136




Registration number
NCT00682136
Ethics application status
Date submitted
20/05/2008
Date registered
22/05/2008
Date last updated
3/06/2010

Titles & IDs
Public title
Analgesic Efficacy of Local Anesthetic Transversus Abdominis Plane (TAP) Blocks in Abdominal Surgery
Scientific title
Efficacy of Local Anesthetic TAP Blocks in Providing Pain Relief Following Laparoscopic and Open Abdominal Surgery
Secondary ID [1] 0 0
08/02/20/3.02
Secondary ID [2] 0 0
TAPTRIAL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - US-Guided Ropivacaine TAP Block

Active comparator: 1 - Open Laparotomy Arm: All patients enrolled in the study who are undergoing elective open laparotomy surgery.

Active comparator: 2 - Laparoscopic Arm: All patients enrolled in the study who are undergoing elective laparoscopic abdominal surgery.


Treatment: Surgery: US-Guided Ropivacaine TAP Block
Bilateral injection of local anaesthetic into the Transversus Abdominis plane, guided by ultrasound.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
mg/kg of morphine equivalent used by patients post operatively.
Timepoint [1] 0 0
From operation until discharge.
Secondary outcome [1] 0 0
Lung Function (spirometry), including FVC, FEV1 and PEFR
Timepoint [1] 0 0
24, 48 and 72 hours postoperatively
Secondary outcome [2] 0 0
Visual Analogue Scale for pain at rest, deep breathing and coughing.
Timepoint [2] 0 0
24, 48 and 72 hours postoperatively

Eligibility
Key inclusion criteria
* All patients aged 18 and over undergoing elective open or laparoscopic colorectal surgery performed by the participating surgeons within the study period will be considered for the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of adverse reaction to Ropivicaine or similar drug.
* Inability or refusal to give consent
* Coagulopathic
* Severe renal impairment
* Aged <18 years

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
206
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Newcastle Private Hospital - New Lambton
Recruitment hospital [3] 0 0
Private Medical Suites - New Lambton
Recruitment hospital [4] 0 0
Mater Misericordiae Hospital - Waratah
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
2298 - Waratah

Funding & Sponsors
Primary sponsor type
Other
Name
Hunter Colorectal Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The aim of the study is to establish the efficacy of local anaesthetic TAP (transversus abdominis plane) blocks in providing pain relief in the first 24hrs following open or laparoscopic elective abdominal colorectal operations.

TAP blocks involve the injection of local aesthetic (ropivicaine) into the transversus abdominis plane in the abdominal wall. This injection takes place after induction of anaesthesia, but before the commencement of surgery. TAP blocks have been proposed as a potential safer alternative to epidural anaesthesia. The blocks have been extensively used in the Hunter New England system over the last 18 months. As yet there is no clear evidence for there efficacy, hence the need for this trial.

This trial would establish the efficacy of this practice. If the technique proves effective it could be widely used and provide a simpler method of managing post operative pain.
Trial website
https://clinicaltrials.gov/study/NCT00682136
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Draganic, B.Med.,B.Med.Sci.(Hons),FRACS
Address 0 0
Hunter Colorectal Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00682136