Acute Pain
Conditions
Brief summary
The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.
Detailed description
Treatment technique: The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score. If patients have met criterion for discharge to home including pain \<4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement. If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred. Adequate analgesia will be defined as \<3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* those who present for elective robotic assisted hysterectomy
Exclusion criteria
* non english speaking * chronic pain * on opioids greater than 1 weeks * chronic anticoagulation * allergy to local anesthetics * use of spinal or epidural for surgery * lack of patient cooperation * contraindication to regional anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Opioid Use | 0-72 hours after injection | To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Rating Scale | 48-72 hours | This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period. |
| Post Operative Length of Stay | up to 30 days after surgery | To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block |
| Patient Satisfaction as Assessed Via Patient Survey | assessed at 72 hours after injection | To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Liposomal Bupivacaine TAP these patients receive a subcostal TAP with liposomal bupivacaine
liposomal bupivacaine | 28 |
| Bupivacaine TAP These patients receive a subcostal TAP with bupivacaine
Bupivacaine | 30 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Bupivacaine TAP | Liposomal Bupivacaine TAP |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 5 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 25 Participants | 20 Participants |
| Region of Enrollment United States | 58 participants | 30 participants | 28 participants |
| Sex: Female, Male Female | 58 Participants | 30 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| weight | 93.5 kilograms STANDARD_DEVIATION 30.2 | 98.5 kilograms STANDARD_DEVIATION 34.2 | 89.3 kilograms STANDARD_DEVIATION 25.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 30 |
| serious Total, serious adverse events | 0 / 28 | 0 / 30 |
Outcome results
Post Operative Opioid Use
To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block
Time frame: 0-72 hours after injection
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Post Operative Opioid Use | 24.9 micrograms of fentanyl equivalents |
| Bupivacaine TAP | Post Operative Opioid Use | 51.7 micrograms of fentanyl equivalents |
Numerical Rating Scale
This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.
Time frame: 48-72 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Liposomal Bupivacaine TAP | Numerical Rating Scale | 3 scores on a scale |
| Bupivacaine TAP | Numerical Rating Scale | 5 scores on a scale |
Patient Satisfaction as Assessed Via Patient Survey
To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.
Time frame: assessed at 72 hours after injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Liposomal Bupivacaine TAP | Patient Satisfaction as Assessed Via Patient Survey | 26 participants satisfied with pain control |
| Bupivacaine TAP | Patient Satisfaction as Assessed Via Patient Survey | 24 participants satisfied with pain control |
Post Operative Length of Stay
To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
Time frame: up to 30 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Liposomal Bupivacaine TAP | Post Operative Length of Stay | 11 Hours | Standard Deviation 9.1 |
| Bupivacaine TAP | Post Operative Length of Stay | 17 Hours | Standard Deviation 13.9 |