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Post-operative PainNCT01307215

TAP Block: Does Volume Make a Difference?

A study testing Ropivacaine in people with Post-operative Pain, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Post-operative Pain
What is being tested?
Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteCanada
Study dates
Apr 2011to Mar 2013
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years old
  • total abdominal hysterectomy
  • capable of completing informed consent
  • no previous chronic opioid use
  • no previous abdominal wall surgeries

Who cannot join

  • patient refusal
  • contraindication to regional anesthesia: coagulopathy, anticoagulant use, bleeding disorders,
  • local or systemic infection
  • local anesthetic allergy
  • BMI>35

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

Other trials in Canada

About this study

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

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.

Read the detailed 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.

Being tested
Ropivacaine
Keywords
TAP block, incision pain, total hysterectomy
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called naropeine, naropin

    20mLs of 0.5%

  • RopivacaineDrug

    Also called naropeine, naropin

    30mLs of 0.33%

  • RopivacaineDrug

    Also called naropeine, naropin

    40mLs of 0.25%

Study groups in NCT01307215
Study groupRoleWhat they receive
20mLs of 0.5% ropivacaine per sideExperimentalNot described
Receives: Drug: Ropivacaine
30mLs of 0.33% ropivacaine per sideExperimentalNot described
Receives: Drug: Ropivacaine
40mLs of 0.25% ropivacaine per sideExperimentalNot described
Receives: Drug: Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 6 month

Secondary outcomes (7)

  1. 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.

    Measured: 48 hours

  2. Pain scores at 2,6,12,24, and 48 hours post-block.

    Using a visual analog scale, patient pain scores will be assessed.

    Measured: 48 hours

  3. Patient-controlled analgesia opioid requirements at 2,6,12,24 and 48 post-block.

    Record drug consumption at the time intervals

    Measured: 48 hours

  4. Incidence of post-operative nausea and vomiting at 2,6,12,24, and 48 hours.

    Measured: 48 hours

  5. Block failure rate.

    Block failure rate is defined as the lack of any sensory block following the TAP block.

    Measured: 48 hours

  6. Patient's overall satisfaction.

    Using a LIKERT score, patient satisfaction will be measured.

    Measured: 48 hours

  7. Discharge time from PACU.

    The time in which the patient is discharged from the recovery room.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionJan 2013
  4. Study completionMar 2013

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01307215
Sponsor's protocol ID
10-3436
Status last verified
Jun 2026
First submitted
28 Feb 2011
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 20175754

  • 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.

    PubMed 19020158

  • Forero M, Heikkila A, Paul JE, Cheng J, Thabane L. Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial. Pilot Feasibility Stud. 2015 Mar 25;1:10. doi: 10.1186/s40814-015-0002-6. eCollection 2015.

    PubMed 27965789

Questions about this trial

What is this clinical trial studying?

A study testing Ropivacaine in people with Post-operative Pain, run by McMaster University at 1 site in Canada.

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 5 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: finished, as of the sponsor's last update on 10 Jun 2026. 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 Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume. (time frame: 6 month). 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 NCT01307215, 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 10 Jun 2026.

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