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Completed

NCT Number: NCT02996227

Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation, Cleveland, Ohio, United States

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About this study

The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent
  • 18-85 years old
  • ASA Physical Status 1-3
  • Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries
  • Anticipated hospitalization of three nights
  • Expected requirement for parenteral opioids for at least 72 hours for postoperative pain
  • Able to use IV PCA systems.

Exclusion criteria

  • Hepatic disease, e.g. twice the normal levels of liver enzymes
  • Kidney disease, e.g. twice the normal level of serum creatinine
  • Bupivacaine sensitivity or known allergy
  • Women who are pregnant or breastfeeding
  • Anticoagulants considered to be a contraindication for epidural or TAP blocks.
  • Surgeries with high port sites will be excluded

Treatment and study plan

TAP Block

Procedure

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

Epidural Analgesia

Procedure

Epidural catheters will be inserted preoperatively.

Exparel

Drug

Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.

Other names: Liposomal Bupivacaine

Bupivacaine

Drug

Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.

Other names: Marcaine

Primary outcomes

  1. VRS Pain Score

    Time frame: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.

    Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours

  2. Total Opioid Consumption

    Time frame: During the 72 hours after discharge from the PACU.

    Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.

Secondary outcomes

  1. Cumulative Duration of Activity

    Time frame: During the initial 72 postoperative hours.

    defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.

  2. Opioid-related Side Effect

    Time frame: The first, second and third postoperative mornings

    We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.

  3. Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.

    Time frame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.

    Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP <65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours.

  4. Quality of Recovery After Anesthesia

    Time frame: The first and third postoperative mornings

    Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = "none of the time [poor]" to 10 = "all of the time [excellent]"; Conversely, for negative items, 10 = "none of the time [excellent]" to 0 = "all of the time [poor]". Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).

  5. Length of Hospital Stay

    Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks

    The length of hospital stay will be measured as days.

Other outcomes

  1. Duration of Hypoxemia

    Time frame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.

    ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%.

  2. Persistent Postoperative Incisional Pain- MBPI Pain Intensity

    Time frame: At the 90-day follow up

    Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).

  3. Persistent Postoperative Incisional Pain- MBPI Pain Interference

    Time frame: At the 90-day follow up

    Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = "no pain" and 10 = "pain as bad as you can imagine."; and for interference items, 0 = "does not interfere" and 10 = "interferes completely." The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2016
Registry last updated
Jan 31, 2024

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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