Pain, Postoperative
Conditions
Keywords
transversus abdominis plane, postoperative, pain
Brief summary
This clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (TAP) block for post-operative pain control. The transversus abdominis muscle is either side between the lowest rib and the hip bone. Group A subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine injected into the TAP. Group B subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine into the TAP. Group C subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the ON-Q® pump. There will be no placebo group in this study.
Interventions
DRUGBupivacaine
60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
DRUGExparel®
20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
DRUGRopivacaine
40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
Sponsors
Joshua Herskovic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to give written informed consent * Scheduled for open abdominal surgery * American Society of Anesthesiologists physical status 1 to 3
Exclusion criteria
* Inability to understand the study or provide written informed consent * Inability to follow protocol instructions * Complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery * Allergy to local anesthetic agents * Contraindication to regional nerve block such as: * Bleeding disorder * Sepsis * Infection at site of block * Body Mass Index (BMI) \>40 * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Dosage of Narcotic | 3 postoperative days | The total use of analgesic medications will be recorded during the 3 days immediately following surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Vomiting (Events) | 3 postoperative days | Total number of vomiting episodes over the three postoperative days. |
| Patient Reported Pain by VAS Scale | Postoperative Day 1 | Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain. |
| Number of Days Required for a Patient to Get Out of Bed | Assessed daily for up to 3 days post-surgery | Patients will be assessed each day following the day of surgery for the ability to get out of bed. |
| Number of Days Required for a Patient to Walk Unassisted | Assessed daily for up to 3 days post-surgery | Patients will be assessed each day following the day of surgery for the ability to walk unassisted |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Injection of Bupivacaine Subjects will undergo post-operative pain relief treatment with a single injection of Bupivacaine, a local anesthetic injected into the transversus abdominis plane.
Bupivacaine: 60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block. | 4 |
| Single Injection of Exparel® Subjects will undergo post-operative pain relief treatment with a single injection of Exparel®, a liposomal form of bupivacaine, into the transversus abdominis plane
Exparel®: 20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block. | 6 |
| Continuous Infusion of Ropivacaine Subjects will be treated with a continuous infusion of the local anesthetic Ropivacaine with the ON-Q® pump
Ropivacaine: 40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side. | 4 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Single Injection of Bupivacaine | Single Injection of Exparel® | Continuous Infusion of Ropivacaine | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 4 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 2 Participants | 7 Participants |
| Region of Enrollment United States | 4 participants | 6 participants | 4 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 6 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 | 0 / 4 |
Outcome results
Primary
Total Dosage of Narcotic
The total use of analgesic medications will be recorded during the 3 days immediately following surgery.
Time frame: 3 postoperative days
Population: 1 patient in the Continuous Infusion of Ropivacaine group required no narcotics immediately following surgery (recovery room) due to continuing effect of the blockade. Patients are removed from study upon discharge in later postoperative days.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Single Injection of Bupivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 2 | 127.0 Mophine Equivalent Units | Standard Deviation 61 |
| Single Injection of Bupivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 1 | 87.7 Mophine Equivalent Units | Standard Deviation 106.5 |
| Single Injection of Bupivacaine | Total Dosage of Narcotic | Narcotic Use - Day of Surgery - Recovery room | 23.2 Mophine Equivalent Units | Standard Deviation 19.1 |
| Single Injection of Bupivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 0 | 33.0 Mophine Equivalent Units | Standard Deviation 34 |
| Single Injection of Bupivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 3 | 318.0 Mophine Equivalent Units | Standard Deviation 0 |
| Single Injection of Exparel® | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 1 | 139.0 Mophine Equivalent Units | Standard Deviation 194.6 |
| Single Injection of Exparel® | Total Dosage of Narcotic | Narcotic Use - Day of Surgery - Recovery room | 14.4 Mophine Equivalent Units | Standard Deviation 11.8 |
| Single Injection of Exparel® | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 0 | 42.2 Mophine Equivalent Units | Standard Deviation 39.9 |
| Single Injection of Exparel® | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 2 | 103.3 Mophine Equivalent Units | Standard Deviation 112.7 |
| Single Injection of Exparel® | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 3 | 41.6 Mophine Equivalent Units | Standard Deviation 40.6 |
| Continuous Infusion of Ropivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 3 | 68.0 Mophine Equivalent Units | Standard Deviation 0 |
| Continuous Infusion of Ropivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 2 | 44.7 Mophine Equivalent Units | Standard Deviation 36.4 |
| Continuous Infusion of Ropivacaine | Total Dosage of Narcotic | Narcotic Use - Day of Surgery - Recovery room | 35.7 Mophine Equivalent Units | Standard Deviation 22.6 |
| Continuous Infusion of Ropivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 1 | 47.9 Mophine Equivalent Units | Standard Deviation 36.4 |
| Continuous Infusion of Ropivacaine | Total Dosage of Narcotic | Narcotic Use - Postoperative Day 0 | 45.0 Mophine Equivalent Units | Standard Deviation 23.9 |
Secondary
Number of Days Required for a Patient to Get Out of Bed
Patients will be assessed each day following the day of surgery for the ability to get out of bed.
Time frame: Assessed daily for up to 3 days post-surgery
Population: All 3 patients in the Single Injection of Bupivacaine cohort required 1 day to be able to get out of bed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Injection of Bupivacaine | Number of Days Required for a Patient to Get Out of Bed | 1.0 days | Standard Deviation 0 |
| Single Injection of Exparel® | Number of Days Required for a Patient to Get Out of Bed | 0.8 days | Standard Deviation 0.4 |
| Continuous Infusion of Ropivacaine | Number of Days Required for a Patient to Get Out of Bed | 0.3 days | Standard Deviation 0.5 |
Secondary
Number of Days Required for a Patient to Walk Unassisted
Patients will be assessed each day following the day of surgery for the ability to walk unassisted
Time frame: Assessed daily for up to 3 days post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Injection of Bupivacaine | Number of Days Required for a Patient to Walk Unassisted | 1.3 days | Standard Deviation 0.5 |
| Single Injection of Exparel® | Number of Days Required for a Patient to Walk Unassisted | 1.5 days | Standard Deviation 0.5 |
| Continuous Infusion of Ropivacaine | Number of Days Required for a Patient to Walk Unassisted | 1.3 days | Standard Deviation 0.5 |
Secondary
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 2 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Time frame: Postoperative Day 2
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Injection of Bupivacaine | Patient Reported Pain by VAS Scale | 4.2 score on a scale | Standard Deviation 1.6 |
| Single Injection of Exparel® | Patient Reported Pain by VAS Scale | 2.0 score on a scale | Standard Deviation 1.2 |
| Continuous Infusion of Ropivacaine | Patient Reported Pain by VAS Scale | 5.3 score on a scale | Standard Deviation 1.9 |
Secondary
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 1 day post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Time frame: Postoperative Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Injection of Bupivacaine | Patient Reported Pain by VAS Scale | 4.4 score on a scale | Standard Deviation 0.4 |
| Single Injection of Exparel® | Patient Reported Pain by VAS Scale | 3.8 score on a scale | Standard Deviation 0.9 |
| Continuous Infusion of Ropivacaine | Patient Reported Pain by VAS Scale | 4.5 score on a scale | Standard Deviation 0.4 |
Secondary
Patient Reported Pain by VAS Scale
Patients will rate their pain by VAS scale 3 days post surgery. Scale is a 0 to 10 visual analog scale with 0 representing no pain and 10 representing severe pain.
Time frame: Postoperative Day 3
Population: Two patients in each of the Single Injection of Bupivacaine and Continuous Infusion of Ropivacaine groups were discharged prior to post-operative day 3. Pain rating data for these subjects were not collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Single Injection of Bupivacaine | Patient Reported Pain by VAS Scale | 4.0 score on a scale | Standard Deviation 0 |
| Single Injection of Exparel® | Patient Reported Pain by VAS Scale | 2.2 score on a scale | Standard Deviation 1.2 |
| Continuous Infusion of Ropivacaine | Patient Reported Pain by VAS Scale | 3.8 score on a scale | Standard Deviation 0.8 |
Secondary
Postoperative Vomiting (Events)
Total number of vomiting episodes over the three postoperative days.
Time frame: 3 postoperative days
Population: No vomiting events were reported by any study subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Injection of Bupivacaine | Postoperative Vomiting (Events) | 0 Vomiting Events |
| Single Injection of Exparel® | Postoperative Vomiting (Events) | 0 Vomiting Events |
| Continuous Infusion of Ropivacaine | Postoperative Vomiting (Events) | 0 Vomiting Events |