Condition category
Surgery
Date applied
11/03/2014
Date assigned
22/04/2014
Last edited
06/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 Then the needle will be withdrawn gently for about 0.5 cm, and the injection will be employed.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

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

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

Sponsor information

Organisation

Mayo General Hospital (Ireland)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25899736

Publication citations

Additional files

Editorial Notes