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Phase 3 Completed N=78 Randomized Double-blind Treatment

ESP Block VS TAP in Laparoscopic Hysterectomy

Source: ClinicalTrials.gov NCT04003987 ↗
Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcomePrimary: Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. — 2.8; 3 score on a scale
◆ Published Evidence
Highly cited
371citations · ~53 / year
The erector spinae plane (ESP) block: A pooled review of 242 cases.
Journal of clinical anesthesia · 2019 · High-confidence link

Summary

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).

Linked Publications (5)

  • The erector spinae plane (ESP) block: A pooled review of 242 cases.
    Journal of clinical anesthesia · 2019 · 371 citations · High-confidence link
  • Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis.
    Journal of minimally invasive gynecology · 2019 · 73 citations · High-confidence link
  • Estimating the Effect of Intravenous Acetaminophen for Postoperative Pain Management on Length of Stay and Inpatient Hospital Costs.
    Advances in therapy · 2017 · 53 citations · Open access · High-confidence link
  • Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report.
    Journal of pain research · 2018 · 49 citations · Open access · High-confidence link
  • Local injection of liposomal bupivacaine combined with intravenous dexamethasone reduces postoperative pain and hospital stay after shoulder arthroplasty.
    Journal of shoulder and elbow surgery · 2017 · 39 citations · High-confidence link

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour.
2.8; 3
PRIMARY
Visual Analogue Scale (VAS) Pain Scores at Rest at 24 Hours.
3; 2.8
PRIMARY
Visual Analogue Scale (VAS) Pain Scores at Rest at 48 Hours.
2.1; 2
PRIMARY
Visual Analogue Scale (VAS) Pain Scores With Movement at 1 Hour.
3; 3.5
PRIMARY
Visual Analogue Scale (VAS) Pain Scores With Movement at 24 Hours.
4.3; 4.1
PRIMARY
Visual Analogue Scale (VAS) Pain Scores With Movement at 48 Hours.
3.4; 3.2
SECONDARY
Patient Sedation Score at 1 Hour
15; 15; 23; 24
SECONDARY
Patient Sedation Score at 24 Hours
2; 1; 34; 38
SECONDARY
Patient Sedation Score at 48 Hours
0; 1; 35; 38
SECONDARY
Patient Nausea Score at 1 Hour
5; 6; 33; 33
SECONDARY
Patient Nausea Score at 24 Hour
11; 7; 25; 32
SECONDARY
Patient Nausea Score at 48 Hour
2; 7; 33; 32
SECONDARY
Patient Satisfaction Score at 24 Hours
3.7; 3.6
SECONDARY
Patient Satisfaction Score at 48 Hours
3.7; 3.7

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04003987) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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