TAP Block: Does Volume Make a Difference?

Post-operative Pain Clinical Trial

Official title:

Lumbar Transversus Abdominal Plane (TAP) Block: Does Volume Make a Difference?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01307215
• Other study ID #: 10-3436
• Status: Completed
• Phase: N/A
• First received: February 28, 2011
• Last updated: April 23, 2013
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: May 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• Ropivacaine
20mLs of 0.5%
• Ropivacaine
30mLs of 0.33%
• Ropivacaine
40mLs of 0.25%

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.	This will be shown as a number and a percenttage of patients recruited and randomized.	6 month	No
Secondary	Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.	The assessor will measure the extend of the block distribution at the various time intervals.	48 hours	No
Secondary	Pain scores at 2,6,12,24, and 48 hours post-block.	Using a visual analog scale, patient pain scores will be assessed.	48 hours	No
Secondary	Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.	Record drug consumption at the time intervals	48 hours	No
Secondary	Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.		48 hours	No
Secondary	Block failure rate.	Block failure rate is defined as the lack of any sensory block following the TAP block.	48 hours	No
Secondary	Patient's overall satisfaction.	Using a LIKERT score, patient satisfaction will be measured.	48 hours	No
Secondary	Discharge time from PACU.	The time in which the patient is discharged from the recovery room.	24 hours	No