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Completed

NCT Number: NCT01848951

Comparison of Epidural and TAP Block in Abdominal Surgery

This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.

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Key information

Conditions

Acute Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Regional Anesthesia Signs and Symptoms Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • subject >/= 19 years of age
  • Undergoing major abdominal surgery
  • able to provide written informed consent

Exclusion criteria

  • chronic opioid use
  • allergies to amide anesthetics
  • inability to undergo general anesthesia
  • pregnancy
  • any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs
  • or evidence of gross neurological dysfunction of the lower extremity

Treatment and study plan

Epidural

Drug

The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.

Other names: local anesthetic

TAP Block

Drug

The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2)

Other names: transversus abdominis plane, abdominal muscle anesthesia

Primary outcomes

  1. Pain scores

    Time frame: 96 hours post-op

    Comparison of pain scores (0 = no pain to 10 = worst pain possible)

  2. Opioid Consumption in a 24-Hour period

    Time frame: 96 hours post-op

    A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions

Secondary outcomes

  1. Comparison of 96-hour hospital stay costs

    Time frame: 96 hours post-op

    Comparison of 96-hour hospital stay cost between the interventions

  2. Comparison of urinary failure/catheter acquired infection rates

    Time frame: 96 hours post-op

    Comparison of urinary failure/catheter acquired infection rates between the interventions

  3. Comparison of hypotension rates

    Time frame: 96 hours post-op

    Comparison hypotension rates between the interventions

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 8, 2013
Registry last updated
Nov 28, 2023

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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