Hemorrhoid
Conditions
Keywords
Liposomal Bupivacaine, Exparel
Brief summary
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
Interventions
DRUGExparel
266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
DRUGBupivacaine HCl with Epinephrine
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
DRUGNormal Saline
30mL Normal Saline
Sponsors
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI\<30
Exclusion criteria
* contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati\>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Control | up to 4 days | The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Oxycodone Tablets Taken | up to 4 days | Number of postoperative opioid consumption - oxycodone tablets (5mg each) |
| Postoperative Opioid Consumption - Hydromorphone I.V | 1 hour and 2 hours post op | — |
| Number of Participants With Postoperative Nausea and Vomiting | up to 4 days | Number of participants with postoperative nausea and vomiting episodes |
| Number of Participants With Pain During Bowel Movements | Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days | Number of participants with pain during postoperative bowel movements |
| Number of Participants With Urinary Retention | up to 4 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL) | 5 |
| Bupivacaine HCl With Epinephrine 75mg/30mL 0.25% Bupivacaine HCl with epinephrine | 4 |
| Normal Saline 30mL Normal Saline | 2 |
| Total | 11 |
Baseline characteristics
| Characteristic | Exparel | Bupivacaine HCl With Epinephrine | Normal Saline | Total |
|---|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 14.61 | 40.75 years STANDARD_DEVIATION 13.1 | 51.5 years STANDARD_DEVIATION 9.19 | 44.54 years STANDARD_DEVIATION 10.36 |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 1 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 4 | 0 / 2 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 2 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 2 |
Outcome results
Primary
Post Operative Pain Control
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Time frame: up to 4 days
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exparel | Post Operative Pain Control | Day 2 | 3 score on a scale |
| Exparel | Post Operative Pain Control | Day 1 | 5.75 score on a scale |
| Exparel | Post Operative Pain Control | Hour 2 | 0 score on a scale |
| Exparel | Post Operative Pain Control | Day 4 | 2.67 score on a scale |
| Exparel | Post Operative Pain Control | Day 3 | 2.25 score on a scale |
| Exparel | Post Operative Pain Control | Hour 1 | 0 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Day 1 | 6.5 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Day 2 | 4.5 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Hour 1 | 1.33 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Hour 2 | 1.0 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Day 3 | 5.0 score on a scale |
| Bupivacaine HCl With Epinephrine | Post Operative Pain Control | Day 4 | 3.0 score on a scale |
| Normal Saline | Post Operative Pain Control | Day 2 | 4 score on a scale |
| Normal Saline | Post Operative Pain Control | Day 4 | 2 score on a scale |
| Normal Saline | Post Operative Pain Control | Day 3 | 3 score on a scale |
| Normal Saline | Post Operative Pain Control | Day 1 | 5.5 score on a scale |
| Normal Saline | Post Operative Pain Control | Hour 2 | 2.5 score on a scale |
| Normal Saline | Post Operative Pain Control | Hour 1 | 7 score on a scale |
Secondary
Number of Oxycodone Tablets Taken
Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Time frame: up to 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exparel | Number of Oxycodone Tablets Taken | Hour 1 | 0 tablets | Standard Deviation 0 |
| Exparel | Number of Oxycodone Tablets Taken | Hour 2 | 0 tablets | Standard Deviation 0 |
| Exparel | Number of Oxycodone Tablets Taken | Day 1 | 2.2 tablets | Standard Deviation 2.28 |
| Exparel | Number of Oxycodone Tablets Taken | Day 2 | 2 tablets | Standard Deviation 1.58 |
| Exparel | Number of Oxycodone Tablets Taken | Day 3 | 1.4 tablets | Standard Deviation 1.52 |
| Exparel | Number of Oxycodone Tablets Taken | Day 4 | 2 tablets | Standard Deviation 1.63 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Day 4 | 1 tablets | Standard Deviation 0 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Hour 1 | 0 tablets | Standard Deviation 0 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Day 2 | 1.67 tablets | Standard Deviation 0.58 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Day 3 | 1.5 tablets | Standard Deviation 0.78 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Hour 2 | 0 tablets | Standard Deviation 0 |
| Bupivacaine HCl With Epinephrine | Number of Oxycodone Tablets Taken | Day 1 | 2.67 tablets | Standard Deviation 1.53 |
| Normal Saline | Number of Oxycodone Tablets Taken | Hour 2 | 0 tablets | Standard Deviation 0 |
| Normal Saline | Number of Oxycodone Tablets Taken | Day 1 | 1.5 tablets | Standard Deviation 0.71 |
| Normal Saline | Number of Oxycodone Tablets Taken | Day 4 | 1.5 tablets | Standard Deviation 0.71 |
| Normal Saline | Number of Oxycodone Tablets Taken | Day 2 | 2.5 tablets | Standard Deviation 0.71 |
| Normal Saline | Number of Oxycodone Tablets Taken | Hour 1 | 0 tablets | Standard Deviation 0 |
| Normal Saline | Number of Oxycodone Tablets Taken | Day 3 | 2.5 tablets | Standard Deviation 0.71 |
Secondary
Number of Participants With Pain During Bowel Movements
Number of participants with pain during postoperative bowel movements
Time frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Number of Participants With Pain During Bowel Movements | Day 1 | 1 Participants |
| Exparel | Number of Participants With Pain During Bowel Movements | Day 2 | 2 Participants |
| Exparel | Number of Participants With Pain During Bowel Movements | Day 3 | 5 Participants |
| Exparel | Number of Participants With Pain During Bowel Movements | Day 4 | 5 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Pain During Bowel Movements | Day 4 | 4 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Pain During Bowel Movements | Day 1 | 1 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Pain During Bowel Movements | Day 3 | 4 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Pain During Bowel Movements | Day 2 | 3 Participants |
| Normal Saline | Number of Participants With Pain During Bowel Movements | Day 4 | 2 Participants |
| Normal Saline | Number of Participants With Pain During Bowel Movements | Day 2 | 1 Participants |
| Normal Saline | Number of Participants With Pain During Bowel Movements | Day 3 | 2 Participants |
| Normal Saline | Number of Participants With Pain During Bowel Movements | Day 1 | 1 Participants |
Secondary
Number of Participants With Postoperative Nausea and Vomiting
Number of participants with postoperative nausea and vomiting episodes
Time frame: up to 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Hour 1 | 0 Participants |
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Hour 2 | 0 Participants |
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Day 1 | 0 Participants |
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Day 2 | 0 Participants |
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Day 3 | 0 Participants |
| Exparel | Number of Participants With Postoperative Nausea and Vomiting | Day 4 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Day 4 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Hour 1 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Day 2 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Day 3 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Hour 2 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Postoperative Nausea and Vomiting | Day 1 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Hour 2 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Day 1 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Day 4 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Day 2 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Hour 1 | 0 Participants |
| Normal Saline | Number of Participants With Postoperative Nausea and Vomiting | Day 3 | 0 Participants |
Secondary
Number of Participants With Urinary Retention
Time frame: up to 4 days
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Exparel | Number of Participants With Urinary Retention | Day 4 | 0 Participants |
| Exparel | Number of Participants With Urinary Retention | Day 3 | 0 Participants |
| Exparel | Number of Participants With Urinary Retention | Day 1 | 0 Participants |
| Exparel | Number of Participants With Urinary Retention | Day 2 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Urinary Retention | Day 1 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Urinary Retention | Day 2 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Urinary Retention | Day 3 | 0 Participants |
| Bupivacaine HCl With Epinephrine | Number of Participants With Urinary Retention | Day 4 | 0 Participants |
| Normal Saline | Number of Participants With Urinary Retention | Day 3 | 0 Participants |
| Normal Saline | Number of Participants With Urinary Retention | Day 1 | 0 Participants |
| Normal Saline | Number of Participants With Urinary Retention | Day 2 | 0 Participants |
| Normal Saline | Number of Participants With Urinary Retention | Day 4 | 0 Participants |
Secondary
Postoperative Opioid Consumption - Hydromorphone I.V
Time frame: 1 hour and 2 hours post op
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exparel | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 1 | 0.35 mg | Standard Deviation 0.47 |
| Exparel | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 2 | 0.5 mg | Standard Deviation 0.6 |
| Bupivacaine HCl With Epinephrine | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 1 | 0 mg | Standard Deviation 0 |
| Bupivacaine HCl With Epinephrine | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 2 | 0 mg | Standard Deviation 0 |
| Normal Saline | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 1 | 0.8 mg | Standard Deviation 0.42 |
| Normal Saline | Postoperative Opioid Consumption - Hydromorphone I.V | Hour 2 | 0.6 mg | Standard Deviation 0.28 |