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Completed

NCT Number: NCT04003987

ESP Block VS TAP in Laparoscopic Hysterectomy

The purpose of this study is to compare the difference between two different pain control methods in patients who will be having a hysterectomy surgery. By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (nausea, sedation, ileus, urinary retention, respiratory depression).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Indiana Univeristy, Indianapolis, Indiana, United States

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About this study

For the TAP block, the ultrasound probe is placed transverse to the abdominal wall, between the iliac crest and the costal margin. The needle is placed in the plane of the probe and advanced until it is between the internal oblique and the transversus abdominis muscles. Once in the plane, 2 mL of saline is injected to confirm needle position, then the local anesthetic solution is injected. [10]

For the ESP block, as mentioned previously, the ultrasound is positioned in a parasagittal fashion, 2-3 inches lateral to the spinous process. This approach visualizes the transverse process. The needle is inserted cranial-to-caudal to make contact with the shadow of the transverse process, with the needle tip deep to the fascial plane of the erector spinae muscle. Injection of saline confirms the location of the needle, and the anesthetic is injected.

All patients will receive PO acetaminophen and PO gabapentin the morning of surgery. Pt. will be placed on PRN oxycodone/acetaminophen (Percocet) postoperatively. PRN IV dilaudid may be given for severe breakthrough pain.

Opioid usage at 1, 24 and 48 hours after the block will be recorded by a member of the research team. Pain scores at rest and on movement will be measured by the investigator using Visual Analog Scale (VAS). Nausea will be measured using a categorical scoring system (none=0; mild=1; moderate=2; severe=3). Sedation scores will also be assessed by a member of the study team using a sedation scale (awake and alert=0; quietly awake=1; asleep but easily roused=2; deep sleep=3). All these parameters will be measured at 1, 24 and 48 hours after the blocks and patients will be encouraged to ambulate on postoperative day 1 under supervision. Their ambulation activity will be recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic hysterectomy surgery at Indiana University Hospital
  • ASA class 1, 2, 3 or 4
  • Age 18 or older, female
  • Desires Regional anesthesia for postoperative pain control

Exclusion criteria

  • History of substance abuse in the past 6 months.
  • Patients on more than 30 mg morphine equivalents of opioids.
  • Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
  • Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine).
  • Postoperative intubation.
  • Any BMI greater than 40.0.

Treatment and study plan

Liposomal bupivacaine

Drug

20ml

Other names: Exparel

bupivacaine, 0.125%

Drug

60ml

Other names: bupivacaine

Primary outcomes

  1. Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.

    Time frame: 1 hour after surgery

    Visual Analogue Scale (VAS) score taken at rest is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

  2. Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.

    Time frame: 24 hours after surgery

    Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain (scale 0-10)

  3. Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.

    Time frame: 48 hours after surgery

    Visual Analogue Scale (VAS) score taken at rest measured as minimal to maximal; higher values mean worse pain(scale 0-10)

  4. Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.

    Time frame: 1 hour after surgery

    Visual Analogue Scale (VAS) score taken with movement is measured as minimal to maximal; higher values mean worse pain (scale 0-10)

  5. Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.

    Time frame: 24 hours after surgery

    Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain (scale 0-10)

  6. Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.

    Time frame: 48 hours after surgery

    Visual Analogue Scale (VAS) score taken with movement measured as minimal to maximal; higher values mean worse pain(scale 0-10)

Secondary outcomes

  1. Patient Sedation Score at 1 Hour

    Time frame: 1 hour after surgery

    Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

  2. Patient Sedation Score at 24 Hours

    Time frame: 24 hours after surgery

    Sedation is measured as minimum to maximum aware ness/level of consciousness: higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

  3. Patient Sedation Score at 48 Hours

    Time frame: 48 hours after surgery

    Sedation is measured as minimum to maximum awareness/level of consciousness; higher values means worse or less awareness (awake, asleep but arousable, deep sleep)

  4. Patient Nausea Score at 1 Hour

    Time frame: 1 hour after surgery

    Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

  5. Patient Nausea Score at 24 Hour

    Time frame: 24 hour after surgery

    Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

  6. Patient Nausea Score at 48 Hour

    Time frame: 48 hour after surgery

    Nausea is measured as minimum to maximum: higher values is worse (none, mild, moderate, severe)

  7. Patient Satisfaction Score at 24 Hours

    Time frame: 24 hours after surgery

    patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)

  8. Patient Satisfaction Score at 48 Hours

    Time frame: 48 hours after surgery

    patient satisfaction is measured as minimum to maximum 1-5; the higher the score the better satisfied (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Erector Spinae Plane Block Versus Transverse Abdominis Plane Block in Laparoscopic Hysterectomy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jul 1, 2019
Registry last updated
Jul 5, 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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