Clinical trial NCT01144273: Transversus Abdominis Plane Block From Abdominal Approach
Official title: Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Transversus Abdominis Plane Block From Abdominal Approach
Lead sponsor: United Christian Hospital
Sponsor class: OTHER
First posted: 2010-06-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.

Detailed description: Potential advantages compared to percutaneous approach are decrease in risk of visceral injury as it is under direct visual and tactile guidance, ease of approach in obese patients, short theatre time for administration, easy to administer.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* Age 18 or above
* Scheduled to undergo TAH+/- salpingoophorectomy.
* Scheduled to receive general anaesthesia under standardized anaesthetic regime.
* Comprehends how to use intravenous patient controlled analgesia (IV PCA).
* Is willing to complete the postoperative assessment.
* Understands the nature and purpose of this study and the study procedures and has signed the informed consent form for this study to indicate this understanding.

Exclusion Criteria:

* Known allergy to drugs involved in this study
* Previously taking medications thought to result in opioid tolerance, or analgesics thought to interfere with subsequent opioid requirement.
* Undergoing any procedures in addition to TAH+/- salpingoophorectomy.
* With co-existing pathology resulting in persistent pain requiring analgesics.
* Wound incision extending to supra-umbilical level.

Primary outcomes:
measure: postoperative 24hr morphine consumption
timeFrame: 24 hours
Secondary outcomes:
measure: morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
timeFrame: 24hrs
measure: Degree on pain according to numerical pain score on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after during rest and movement (cough
timeFrame: 24hrs
measure: incidence of nausea and vomiting
timeFrame: 24hours postoperatively
Other outcomes:
Locations:
city: Kwun Tong
country: Hong Kong
facility: Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital
state: Kowloon
Study officials:
affiliation: United Christian Hospital, Hospital Authority
name: Wing Yee Lillian Choy, MBBS (HK)
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
citation: Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
citation: Bonnet F, Berger J, Aveline C. Transversus abdominis plane block: what is its role in postoperative analgesia? Br J Anaesth. 2009 Oct;103(4):468-70. doi: 10.1093/bja/aep243. No abstract available.