Transversus Abdominis Plane Block From Abdominal ApproachNCT01144273
Transversus Abdominis Plane Block From Abdominal Approach
A study testing Transversus abdominis plane block in people with Transversus Abdominis Plane Block From Abdominal Approach, run by United Christian Hospital at 1 site in Hong Kong.
Trial summary
Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Transversus Abdominis Plane Block From Abdominal Approach
- What is being tested?
- Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department Of Anaesthesiology, Pain medicine and Operating Services. United Christian Hospital
Kwun Tong, Kowloon
Wing Yee Lillian Choy, MBBS (HK), 3513 4245
Wing Yee Lillian Choy, MBBS (HK)
About this study
Official title: Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.
Read the detailed 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.
- Being tested
- Transversus abdominis plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockProcedure or surgery
Also called TAP 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.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% Ropivacaine | Active comparator | group receiving TAP block (0.5% ropivacaine at TAP plane) Receives: Procedure: Transversus abdominis plane block |
| normal saline | Placebo comparator | group receiving placebo (saline) at TAP plane Receives: Procedure: Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
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.
Measured: 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
Measured: 24hrs
incidence of nausea and vomiting
Measured: 24hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transversus Abdominis Plane Block From Abdominal ApproachStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wing Yee Lillian Choy, MBBS (HK), Principal investigator, United Christian Hospital, Hospital Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144273
- Sponsor's protocol ID
- Protocol ver 1.1
- Other IDs
- KC/KE-10-0021/FR-3
- Status last verified
- Jun 2010
- First submitted
- 14 Jun 2010
- Last updated
- 30 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17179269Carney 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.
PubMed 19020158Bonnet 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.
PubMed 19749115
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Block From Intraabdominal Approach in Patients Undergoing Total Abdominal Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01144273
- Acronym / sponsor ID
- Protocol ver 1.1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 15 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized double blind placebo controlled trial on transversus abdominus plane block approached from abdominal cavity, in patients undergoing total abdominal hysterectomy.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% Ropivacaine | Active comparator | Procedure: Transversus abdominis plane blockgroup receiving TAP block (0.5% ropivacaine at TAP plane) |
| normal saline | Placebo comparator | Procedure: Transversus abdominis plane blockgroup receiving placebo (saline) at TAP plane |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversus abdominis plane blockAlso: TAP blockThis 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. | Procedure or surgery | 0.5% Ropivacaine, normal saline |
Primary outcome
postoperative 24hr morphine consumption
Time frame: 24 hours
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.
3 secondary outcomes
morphine consumption on arrival to post-anaesthetic care unit(PACU) and 4, 12 and 24 hours after.
Time frame: 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
Time frame: 24hrs
incidence of nausea and vomiting
Time frame: 24hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2010.
- Background: PubMed 17179269McDonnell 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.
- Background: PubMed 19020158Carney 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.
- Background: PubMed 19749115Bonnet 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wing Yee Lillian Choy, MBBS (HK) principal investigator
United Christian Hospital, Hospital Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block in people with Transversus Abdominis Plane Block From Abdominal Approach, run by United Christian Hospital at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wing Yee Lillian Choy, MBBS (HK) (3513 4245, cwy027@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative 24hr morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01144273, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2010.