Comparing Laproscopically delivered Local Anaesthetic Transversus Abdominis Plane Block to Infiltration of local anaesthetic to the ports wounds

ISRCTN ISRCTN46581210
DOI https://doi.org/10.1186/ISRCTN46581210
Secondary identifying numbers N/A
Submission date
11/03/2014
Registration date
22/04/2014
Last edited
06/10/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 Then the needle will be withdrawn gently for about 0.5 cm, and the injection will be employed.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

Contact information

Mr Ghassan Elamin
Scientific

4 Blackfort Avenue
Newport Road
Castlebar
Co. Mayo
Ireland

Phone +353 (0)873 252 865
Email ghassan@live.ie

Study information

Study designSingle-centre interventional prospective randomized double-blinded parallel trial
Primary study designInterventional
Secondary study designRandomised parallel trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of a Laparoscopically delivered Transversus Abdominis Plane Block Technique During Elective Laparoscopic Cholecystectomy; a Prospective Double Blind Randomized Trial
Study objectivesA 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(s)Mayo General Hospital Clinical Research Ethics Committee, 10/04/2013, ref: MGH/CR/145-13
Health condition(s) or problem(s) studiedLaparoscopic cholecystectomy
InterventionTest 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 typeProcedure/Surgery
Primary outcome measurePain score at rest and while coughing using the numerical Visual Analog Scale (VAS) at 1, 3, 6 hrs.
Secondary outcome measures1. Analgesics requirements (paracetamol and NSAID).
2. Nausea and vomiting
3. Pain scoring will be recorded using VAS at 12, 24 hrs.
Overall study start date01/05/2013
Completion date01/04/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants80 patients, with 40 in each arm
Key inclusion criteria1. All consecutive ASA grade I-II patients undergoing elective laparoscopic cholecystectomy
2. Age 18 - 85
Key exclusion criteria1. 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
Date of first enrolment01/05/2013
Date of final enrolment01/04/2014

Locations

Countries of recruitment

  • Ireland

Study participating centre

4 Blackfort Avenue
Castlebar
Co. Mayo
Ireland

Sponsor information

Mayo General Hospital (Ireland)
Hospital/treatment centre

c/o Iqbal Z. Khan (supervisor)
General Surgery Dept.
Old Westport Street
Castlebar
Co. Mayo
Ireland

ROR logo "ROR" https://ror.org/02z8t9146

Funders

Funder type

Hospital/treatment centre

Mayo General Hospital (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2015 Yes No