Phase 3
N=78
ESP Block VS TAP in Laparoscopic Hysterectomy
Hysterectomy
Bottom Line
View on ClinicalTrials.gov: NCT04003987 ↗Enrolled (actual)
78
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Visual Analogue Scale (VAS) Pain Scores at Rest at 1 Hour. — 2.8; 3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal bupivacaine (Drug); bupivacaine, 0.125% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Indiana University
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-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 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT04003987). 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.