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Completed

NCT Number: NCT01307215

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.

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ropivacaine

Drug

20mLs of 0.5%

Other names: naropeine, naropin

Primary outcomes

  1. To assess the feasibility of a large scale clinical study to determine the influence on increasing the local anesthetic volume.

    Time frame: 6 month

    This will be shown as a number and a percenttage of patients recruited and randomized.

Secondary outcomes

  1. Using ice and pinprick, determine the dermatomal block distribution at 2,6,12,24 and 48 hours post block.

    Time frame: 48 hours

    The assessor will measure the extend of the block distribution at the various time intervals.

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

    Time frame: 48 hours

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

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

    Time frame: 48 hours

    Record drug consumption at the time intervals

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

    Time frame: 48 hours

  5. Block failure rate.

    Time frame: 48 hours

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

  6. Patient's overall satisfaction.

    Time frame: 48 hours

    Using a LIKERT score, patient satisfaction will be measured.

  7. Discharge time from PACU.

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • St. Joseph's Healthcare Hamilton

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 2, 2011
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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