Phase 4
N=87
TAP vs Surgical Infiltration of Local Anesthetic in Laparoscopic and Robotic Hysterectomy
Acute Pain
Bottom Line
View on ClinicalTrials.gov: NCT02519023 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Total Opioid Use for Pain Control — 20.8; 25.0 mg Morphine equivalents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Liposomal Bupivacaine (Drug); Bupivacaine (Drug); Ultrasound (Device); Epinephrine (Drug); acetaminophen (Drug); ibuprofen (Drug); Oxycodone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Minnesota
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Opioid Use for Pain Control |
20.8; 25.0 | — |
| SECONDARY Maximum Pain Scores as Measured by Numerical Pain Rating Scale (0-10) |
8; 13 | — |
| SECONDARY Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents |
0; 5 | — |
| SECONDARY Quality of Recovery 15 (QoR15) Score |
126; 115 | — |
| SECONDARY Overall Benefit of Analgesia Score (OBAS) |
2; 3 | — |
| SECONDARY Number of Participants With Nausea and Vomiting |
10; 16 | — |
| SECONDARY Length of Time in Phase 1 and Phase 2 of Recovery |
3.3; 3.1 | — |
| SECONDARY Number of Patients Admitted Post Operatively |
11; 16 | — |
| SECONDARY Opioid Used From 24-48 Hours Post Surgery |
0; .5 | — |
| SECONDARY Total Opioid Taken by Patient as Tabulated and Converted to Morphine Equivalents |
0; 5 | — |
| SECONDARY Patient Satisfaction With Pain Management |
30; 24 | — |
| SECONDARY Maximal Pain Score of Patient From Time 0-24 Hours After Surgery |
3; 5 | — |
| SECONDARY Maximal Pain Score for Patient From Time 24-48 Hours After Surgery |
3; 4 | — |
| SECONDARY Maximal Pain Score Patient Felt From 48-72 Hours After Surgery |
2; 3 | — |
Summary
Laparoscopic and Robotic assisted hysterectomy is a surgical procedure that is a minimally invasive way in which to remove the uterus, which has less scarring and fewer complications. However, this procedure, much like its open-surgical counterpart, is often associated with significant post-operative pain. To augment this pain there are many different analgesic techniques available to offset pain. Ultrasound-guided transversus abdominis plane (TAP) block is one such procedure involving the injection of a local anesthetic into the plane of the transversus abdominal muscle where the terminal branches of nerves lie. A similar, yet different analgesic approach is that of direct injection of local anesthetic into the incision by the surgeon during or just after surgical procedures. These two approaches have both been proven to decrease post-operative pain in patients for many procedures, but never compared to one another.
Eligibility Criteria
Inclusion Criteria
- ASA physical status I-III
- Females >/=18-years of age
- Scheduled for laparoscopic/robot-assisted hysterectomy.
Exclusion Criteria
- Contraindication to surgical infiltration or regional blockade
- History of long term opioid intake (greater than 3 weeks prior to surgery) or chronic pain disorder
- Inability to understand the informed consent and demands of the study
- Surgery scheduled to start after 1700
Data sourced from ClinicalTrials.gov (NCT02519023). 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.