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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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

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

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
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 290584 0
Self funded/Unfunded
Name [1] 290584 0
Address [1] 290584 0
Country [1] 290584 0
Primary sponsor type
Dr tarek Fouad Tammam
Suez Canal University Hospital,41511, Ismaillia, Egypt
Secondary sponsor category [1] 289273 0
Name [1] 289273 0
Address [1] 289273 0
Country [1] 289273 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 295190 0
Approval date [1] 295190 0
Ethics approval number [1] 295190 0

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

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
Phone 54166 0
Fax 54166 0
Email 54166 0
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
Phone 54167 0
Fax 54167 0
Email 54167 0
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
Phone 54168 0
Fax 54168 0
Email 54168 0

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