Clinical trial NCT01307215: TAP Block: Does Volume Make a Difference?
Official title: Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Keywords: TAP block
incision pain
total hysterectomy
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2011-03-02
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients who have abdominal surgery will experience pain from the incision. The lumbar TAP block is a procedure used to reach the nerve endings in the abdominal wall so that there is a reduction in pain after surgery. Using ultrasound guidance, a solution of ropivacaine will be injected after surgery. The aim of this study is to determine the effect of changes in the volume of the injection.

Detailed description: Pain from a surgical incision happens in most patients. During the perioperative period, the use of the TAP block has been shown to reduce pain scores, opioid consumption and sedation scores. Also, there is a trend towards a reduction of post-operative nausea and vomiting. The aim of the block is to reach the distal nerve endings of the abdominal wall from T6 to L1 dermatomes using ultrasound guidance with a single shot of ropivacaine at different volumes. Currently, there is consensus about optimal procedure-specific volumes and local anesthetic concentrations for lumbar TAP blocks. This is a pilot study and the purpose being is it feasible to do a large scale clinical study to determine the influence of increasing the local anesthetic volume.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* total abdominal hysterectomy
* capable of completing informed consent
* no previous chronic opioid use
* no previous abdominal wall surgeries

Exclusion Criteria:

* patient refusal
* contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
* local or systemic infection
* local anesthetic allergy
* BMI\>35

Primary outcomes:
measure: To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.
timeFrame: 6 month
Secondary outcomes:
measure: Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.
timeFrame: 48 hours
measure: Pain scores at 2,6,12,24, and 48 hours post-block.
timeFrame: 48 hours
measure: Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.
timeFrame: 48 hours
measure: Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.
timeFrame: 48 hours
measure: Block failure rate.
timeFrame: 48 hours
measure: Patient's overall satisfaction.
timeFrame: 48 hours
measure: Discharge time from PACU.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University/St. Joseph's Healthcare
name: Mauricio Forero, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
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: Forero M, Heikkila A, Paul JE, Cheng J, Thabane L. Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial. Pilot Feasibility Stud. 2015 Mar 25;1:10. doi: 10.1186/s40814-015-0002-6. eCollection 2015.