Transversus Abdominis Plane Block From Abdominal Approach

NCT ID: NCT01144273

Last Updated: 2010-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Transversus Abdominis Plane Block From Abdominal Approach

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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0.5% Ropivacaine

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

Group Type ACTIVE_COMPARATOR

Transversus abdominis plane block

Intervention Type 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.

normal saline

group receiving placebo (saline) at TAP plane

Group Type PLACEBO_COMPARATOR

Transversus abdominis plane block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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TAP block

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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United Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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United Christian Hospital, Hospital Authority

Principal Investigators

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Wing Yee Lillian Choy, MBBS (HK)

Role: PRINCIPAL_INVESTIGATOR

United Christian Hospital, Hospital Authority

Locations

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

Kwun Tong, Kowloon, Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Central Contacts

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Wing Yee Lillian Choy, MBBS (HK)

Role: CONTACT

Phone: 3513 4245

Email: [email protected]

Facility Contacts

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Wing Yee Lillian Choy, MBBS (HK)

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 17179269 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19020158 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19749115 (View on PubMed)

Other Identifiers

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KC/KE-10-0021/FR-3

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol ver 1.1

Identifier Type: -

Identifier Source: org_study_id