Transversus Abdominis Plane Block From Abdominal Approach

Transversus Abdominis Plane Block From Abdominal Approach Clinical Trial

Official title:

Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01144273
• Other study ID #: Protocol ver 1.1
• Secondary ID: KC/KE-10-0021/FR
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2010
• Last updated: June 29, 2010
• Start date: May 2010
• Est. completion date: October 2010

Study information

• Verified date: June 2010
• Source: United Christian Hospital
• Contact: Wing Yee Lillian Choy, MBBS (HK)
• Phone: 3513 4245
• Email: cwy027[@]ha.org.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Transversus Abdominis Plane Block From Abdominal Approach

Intervention

Procedure:
• Transversus abdominis plane block
This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now. To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique. Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer. After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity.

Locations

Country	Name	City	State
Hong Kong	Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital	Kwun Tong	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
United Christian Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (3)

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. — View 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. — View 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. Erratum in: Anesth Analg. 2007 May;104(5):1108. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative 24hr morphine consumption	The primary objective of this study is to demonstrate the effectiveness of tranversus abdominis plane block using the intraabdominal approach in reducing postoperative 24 hours morphine consumption after total abdominal hysterectomy (TAH) where time 0 is taken as time of arrival at PACU.	24 hours	No
Secondary	morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.	• Assess and compare the morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.	24hrs	No
Secondary	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		24hrs	No
Secondary	incidence of nausea and vomiting		24hours postoperatively	No