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Completed

NCT Number: NCT03250507

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

About this study

All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.

Exclusion criteria

  • Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Treatment and study plan

Bupivacaine

Drug

0.25% bupivacaine for TAP block

Other names: Marcaine, Sensorcaine

Liposomal bupivacaine

Drug

Exparel for TAP block

Other names: Exparel

Saline

Drug

Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

Primary outcomes

  1. Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)

    Time frame: 0 - 72 hours post-operatively

    Total opioid consumption

  2. Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given

    Time frame: 0 - 72 hours post-operatively

    time to first opioid given

Secondary outcomes

  1. Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied

    Time frame: 0 - 72 hours post-operatively

    Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.

  2. Length of Stay in the Hospital

    Time frame: until the patient is discharged from the hospital

    Length of stay in the hospital, maximum time until discharge from the hospital

  3. Number of Patients With Local Anesthetic Toxicity

    Time frame: 0 - 72 hours post-operatively

    Presence of local anesthetic toxicity

  4. Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure

    Time frame: 0 - 72 hours post-operatively

    Presence of hemodynamic instability

  5. Pain Scores Using Visual Analogue Scale ( 0-10)

    Time frame: 0-24 postoperative pain scores

    Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2017
Registry last updated
Dec 21, 2022

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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