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Trial registered on ANZCTR


Registration number
ACTRN12615000632594
Ethics application status
Approved
Date submitted
23/01/2015
Date registered
18/06/2015
Date last updated
6/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Laparoscopic-Assisted Psoas blockade: A novel post-operative analgesic technique in patients undergoing laparoscopic inguinal hernia repair
Scientific title
A prospective, randomized, clinical trial to evaluate the effect of laparoscopic-assisted psoas blockade versus transversus abdominis plane (TAP) block on post-operative morphine requirements in male patients undergoing laparoscopic inguinal hernia repair
Secondary ID [1] 286047 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative pain in patients undergoing inguinal hernia repair 293948 0
Condition category
Condition code
Anaesthesiology 294246 294246 0 0
Anaesthetics
Surgery 295477 295477 0 0
Surgical techniques
Oral and Gastrointestinal 295562 295562 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Laparoscopic-Assisted Psoas blockade was conducted after induction of general anesthesia. Under laparoscopic guidance and after achieving proper exposure of the psoas major muscle, a 5-mm horizontal incision was made in the ventral fascia of the psoas major muscle to provide a proper access for the block catheter. Successful catheter placement was confirmed by expansion of the plane between the psoas muscle and its corresponding fascia with 2 ml normal saline injection. After negative aspiration, twenty milliliters of plain bupivicaine (2.5 mg/ml) were incrementally administered through the catheter.
Intervention code [1] 290971 0
Treatment: Drugs
Comparator / control treatment
Transversus abdominis plane (TAP) block.In Group TAP: Ultrasound guided TAP block was performed under complete aseptic technique after induction of the general anesthesia, using a linear array transducer with adjustment of frequency, depth and gain to spot the best view. The ultrasound (Sonosite Inc., Bothel, Washington, USA) probe was initially placed in a plane transverse to the antero-lateral abdominal wall at a level midway between the lower costal margin and iliac crest. A 20-gauge needle (Stimuplex A, B. Braun Melsungen AG, Germany) was introduced 3 cm medial to the ultrasound probe and advanced in a medial to lateral direction toward the target plane (TAP). Once the needle tip was presumed to be in the correct position (confirmed by expansion of transversus abdominis plane as a dark shadow between the internal oblique and the transversus abdominis muscles with 2 ml normal saline injection), twenty milliliters of plain bupivicaine (2.5 mg/ml) was incrementally injected after negative aspiration under real-time imaging.
Control group
Active

Outcomes
Primary outcome [1] 294045 0
The primary outcome measure is the total morphine requirements in the first 36 hours postoperatively
Timepoint [1] 294045 0
First 36 postoperative hours
Secondary outcome [1] 312405 0
The time to first request for analgesia is defined as the time from completion of the block injection (taken as time zero minute) to the first postoperative administration of IV morphine.
Timepoint [1] 312405 0
the time from completion of the block injection (taken as time zero minute) to the first postoperative administration of IV morphine
Secondary outcome [2] 312406 0
The dermatomal sensory involvement of both approaches will be estimated bilaterally with pinprick and thermal tests after block performance. The most proximal and distal levels of sensory involvement will be established if the same dermatome level will be recorded on three consecutive times.
Timepoint [2] 312406 0
The assessment will be done before induction of the anesthesia and at regular 30-min intervals for 3 hours postoperative.
Secondary outcome [3] 312407 0
All patients will be asked to rate their postoperative surgical pain at rest and while coughing by using a numerical rating scale (NRS) (NRS: 0= no pain, 10= worst pain)
Timepoint [3] 312407 0
Assessment will be at regular predefined time intervals (6, 12, 24, and 36 hrs) after completion of the block

Eligibility
Key inclusion criteria
Male patients scheduled for elective laparoscopic unilateral inguinal hernia repair with ASA physical status I–III will be enrolled in the clinical trial.
Minimum age
18 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients that had history of allergy to local anesthetics, obesity (BMI 'greater than or equal to' 30 kg/m2), recurrent hernia, neuropathies, or those on chronic analgesic therapies will be excluded from the study.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6597 0
Egypt
State/province [1] 6597 0

Funding & Sponsors
Funding source category [1] 290584 0
Self funded/Unfunded
Name [1] 290584 0
None
Address [1] 290584 0
None
Country [1] 290584 0
Primary sponsor type
Individual
Name
Dr tarek Fouad Tammam
Address
Suez Canal University Hospital,41511, Ismaillia, Egypt
Country
Egypt
Secondary sponsor category [1] 289273 0
None
Name [1] 289273 0
None
Address [1] 289273 0
None
Country [1] 289273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295190 0
Research ethics committee, Faculty of medicine,Suez canal university
Ethics committee address [1] 295190 0
Suez Canal University Hospital,41511, Ismaillia
Ethics committee country [1] 295190 0
Egypt
Date submitted for ethics approval [1] 295190 0
15/11/2013
Approval date [1] 295190 0
25/12/2013
Ethics approval number [1] 295190 0
2030

Summary
Brief summary
The present study aimed to measure the opioid-sparing effect of the laparoscopic- assisted psoas blockade in comparison with the transversus abdominis plane block in patients undergoing laparoscopic inguinal hernia repair. We hypothesized that the use of laparoscopic- assisted psoas (LAP) blockade can reduce the postoperative analgesic requirements following inguinal herniorraphy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54166 0
Prof Tarek F. Tammam
Address 54166 0
14 st Riad and Orabey St., Portsaid, Egypt/ Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Egypt
Country 54166 0
Egypt
Phone 54166 0
+201099122663
Fax 54166 0
Email 54166 0
tarek1367@hotmail.com
Contact person for public queries
Name 54167 0
Dr Asaad F. Salama
Address 54167 0
Theodore bilharz research institute, PoBox 30 Imbaba 12411 Giza, Egypt
Country 54167 0
Egypt
Phone 54167 0
+201098121412
Fax 54167 0
Email 54167 0
asaadfayrouz@live.com
Contact person for scientific queries
Name 54168 0
Prof Tarek F. Tammam
Address 54168 0
14 st Riad and Orabey St., Portsaid, Egypt/ Department of Anesthesia and Intensive Care, Faculty of Medicine, Suez Canal University Hospital, Egypt
Country 54168 0
Egypt
Phone 54168 0
+201099122663
Fax 54168 0
Email 54168 0
tarek1367@hotmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary