Plain English Summary
Background and study aims
The new laparoscopic Transversus Abdominis Plane (TAP) Block technique is more reliable, solely performed by surgeons, and is supposed to replace the ultra sound-guided method. The latter is time-consuming, need ultra sound skills and is usually done by anaesthetists. Previous reports have shown advantage for the ultra sound -guided TAP block in controlling postoperative pain for several types of abdominal surgery. This study will be the first to evaluate the new method and comparing it with the current practice.
Who can participate?
Adult patients undergoing elective laparoscopic cholecystectomy (gallbladder removal).
What does the study involve?
The surgery will be performed by one of four general surgeons following standardized surgical approach under general anaesthesia, while the TAP Block will be done by one of two surgeons who are familiar with the technique. The intra-abdominal pressure will be set at the same level (12 mm Hg) for all patients.
Participants will be randomly allocated to one of two groups: the test group or the control group.
Test group: The TAP block will be performed bilaterally at four points using a blunt needle at the start of the surgery (the MAX line, mid-point between iliac crest and Subcostal margin, and the anterior axillary line just below the Subcostal margin). All the procedure will be performed under visualization (by the laparoscope). Digital pressure will applied to define the site of injection. The needle will be inserted blindly at the site of injection using till it is visible at the level of the peritoneum. Then the needle will be withdrawn gently for about 0.5 cm, and the injection will be employed. The site of injection will be inspected from within the peritoneal cavity to make sure that no intra-peritoneal injection was done. The presence of internal bulge (Doyle's bulge) is regarded as the definitive point of the procedure.
Control group: Local periportal infiltration will be done at the four ports before the insertion of ports.
What are the possible benefits and risks of participating?
Risks involved would be same as local anaesthetic injections including bleeding, infection, toxicity, and allergic reactions. Possible benefits would be a better pain control if the TAP Block proves to be superior.
Where is the study run from?
The study will be conducted under the responsibility of Department of Surgery and the Department of Anaesthesia, Mayo General Hospital, Ireland
When is the study starting and how long is it expected to run for?
May 2013 to May 2014
Who is funding the study?
Mayo General Hospital, Ireland
Who is the main contact?
Mr Ghassan Elamin
ghassan@live.ie
Trial website
Contact information
Type
Scientific
Primary contact
Mr Ghassan Elamin
ORCID ID
Contact details
4 Blackfort Avenue
Newport Road
Castlebar
Co. Mayo
Ireland
+353 (0)873 252 865
ghassan@live.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Efficacy of a Laparoscopically delivered Transversus Abdominis Plane Block Technique During Elective Laparoscopic Cholecystectomy; a Prospective Double Blind Randomized Trial
Acronym
Study hypothesis
A newly developed technique of TAP block solely performed by surgeons as described by: Chetwood et al. Laparoscopic assisted transversus abdominis plane block: A novel insertion technique during laparoscopic nephrectomy. Anesthesia 2006; 66: 311-22.
It will be used postoperative pain relief following laparoscopic cholecystectomy.
Our alternative hypothesis is that laparoscopic-assisted four-points TAP block is better than the periportal wound infiltration in controlling the postoperative pain.
Ethics approval
Mayo General Hospital Clinical Research Ethics Committee, 10/04/2013, ref: MGH/CR/145-13
Study design
Single-centre interventional prospective randomized double-blinded parallel trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Laparoscopic cholecystectomy
Intervention
Test group intervention : Laparoscopic-assisted transversus abdominis plane (TAP) block, using 50 mls of 0.25% Bupivacaine at four points, and 20 mls of saline as peri portal infilteration.
Control group intervention: peri portal infiltration with 20 mls of 0.5% Bupivacaine, with injecting 50 mils of saline at the TAP space using the four points.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Pain score at rest and while coughing using the numerical Visual Analog Scale (VAS) at 1, 3, 6 hrs.
Secondary outcome measures
1. Analgesics requirements (paracetamol and NSAID).
2. Nausea and vomiting
3. Pain scoring will be recorded using VAS at 12, 24 hrs.
Overall trial start date
01/05/2013
Overall trial end date
01/04/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All consecutive ASA grade I-II patients undergoing elective laparoscopic cholecystectomy
2. Age 18 - 85
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80 patients, with 40 in each arm
Participant exclusion criteria
1. Emergency laparoscopic cholecystectomy
2. ASA grade III, IV, V
3. Converted to open procedures
4. Coagulopathy.
5. Significant liver or renal disease
6. Allergy to Bupivacaine
7. Diagnosis of 'chronic pain syndrome'
8. Known alcohol or substance abuse within the last 6 months.
9. Daily Opioid intake.
10. Abdominal drainage
Recruitment start date
01/05/2013
Recruitment end date
01/04/2014
Locations
Countries of recruitment
Ireland
Trial participating centre
4 Blackfort Avenue
Castlebar
Co. Mayo
Ireland
Funders
Funder type
Hospital/treatment centre
Funder name
Mayo General Hospital (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25899736