Transversus Abdominis Plane Block From Abdominal Approach

NCT01144273 | Unknown DMC

• 2 other identifiers: Protocol ver 1.1KC/KE-10-0021/FR-3
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Transversus Abdominis Plane Block From Abdominal Approach

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.

  24hrs

• 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

• incidence of nausea and vomiting

  24hours postoperatively

Study Arms (2)

0.5% Ropivacaine

ACTIVE COMPARATOR

group receiving TAP block (0.5% ropivacaine at TAP plane)

Procedure: Transversus abdominis plane block

normal saline

PLACEBO COMPARATOR

group receiving placebo (saline) at TAP plane

Procedure: Transversus abdominis plane block

Interventions

Transversus abdominis plane block PROCEDURE

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.

Also known as: TAP block

0.5% Ropivacaine; normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• United Christian Hospital: lead

Study Sites (1)

Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital

Kwun Tong, Kowloon, Hong Kong

RECRUITING

Related Publications (3)

• 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.

  PMID: 17179269 BACKGROUND

• 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.

  PMID: 19020158 BACKGROUND

• 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.

  PMID: 19749115 BACKGROUND

Study Officials

• Wing Yee Lillian Choy, MBBS (HK)

  United Christian Hospital, Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Yee Lillian Choy, MBBS (HK)

CONTACT

3513 4245; cwy027@ha.org.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 15, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 30, 2010

Record last verified: 2010-06

Locations

HK (1)