Postoperative Pain
Conditions
Brief summary
After surgery it is normal to experience some pain at the site of operation. In order to reduce the pain, medication such as Morphine is injected into a vein using a Patient Controlled Analgesia (PCA) pump that is kept at bed side, and is activated by the patient when needed. However, Morphine is an opioid drug, which can cause side effects such as sedation, nausea, vomiting, and reduced breathing on prolonged use. In addition to the opioid drugs, local anesthetics, and other drugs called Non steroidal anti inflammatory drugs (NSAIDs) have been injected locally to provide prolonged pain relief without the side effects of morphine. Recently a portable device called ON-Q pump has been developed to continuously infuse the local anesthetic through 2 small catheters inserted at the wound site. The ON-Q Pump is a small tennis ball sized unit made of a soft synthetic material that slowly infuses the drug through the catheters by elastic force. This pump is very safe and is attached to a bedside pole or the patient's hospital gown. This pump has already been approved by the FDA for clinical use, and has been reported to provide effective pain management after some surgical procedures. The primary aim of the present study is to evaluate the relative efficacy of the drugs Ketorolac and Ropivacaine infused through the ON-Q pump in reducing the pain following gynecologic surgery. Ketorolac and Ropivacaine are approved drugs that are frequently used for post operative pain relief. Our hypothesis is that these two drugs in combination will provide better analgesia than Ketorolac alone.
Detailed description
This study would include a total of 60 patients randomized into 2 equal groups. Patients will be interviewed in the holding area and informed signed consent will be obtained. Patients will be induced with general anesthesia in keeping with standard practice. At the end of surgical procedure, before the patient is extubated, the Surgeon will secure the 2 catheters of the ON-Q pump at two levels of the fascia near the incision site. First the surgeon will instill at the wound site a bolus dose of 30 ml of 0.9% saline with 10 mg Ketorolac in Group I, or 30 ml of saline with 0.5% Ropivacaine and 10 mg Ketorolac in Group II patients. Then the continuous infusion with the ON-Q pump will be started at 4 ml/hr, and Group I patients will receive saline with Ketorolac at 5 mg/hr not to exceed 120 mg per day, and Group II will receive saline with 0.5% Ropivacaine plus Ketorolac at 5 mg/hr. Patients will be extubated, as per standard anesthetic practice. All patients will receive anti ulcer medication. On arrival at the Post Anesthesia Care Unit (PACU), the patient will receive an i.v. PCA pump, which will administer Morphine Sulfate 2 mg in incremental doses on demand by the patient. A blinded investigator will collect the study data from each patient at 6, 12, 24, and 48 hrs postoperative periods. The data collected would include 1) Visual Analog Scale (VAS) scores for pain at rest, on coughing and on moving, 2) PCA demands by the patient and actual deliveries of morphine, 3) rescue analgesic requirements (for pain score of 4 or greater). 4) VAS scores for Nausea, drowsiness, and satisfaction, and 5) number of vomiting.
Interventions
DRUGKetorolac
Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day
DRUGKetorolac and Ropivacaine
Patients will receive Ketorolac at 5 mg/hr plus 0.5% Ropivacaine
Sponsors
I-Flow
Maimonides Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients belonging to ASA class I to II classification who are undergoing abdominal gynecologic surgery will be included in the study.
Exclusion criteria
* Patients who are allergic to NSAIDs, Asthmatics, and those who have peptic ulcer, sepsis, or coagulation problems will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on Movement | 6 hours after surgery | Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
| Pain Scores at Rest | 1 hour after the surgery | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
| Pain Score at Rest | At the end of 6 hours after surgery | Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
| Pain Score on Coughing | 1 hour after the surgery | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
| Pain Scores on Coughing | 6 hours after surgery | Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
| Pain on Movement | 1 hour after surgery | Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Equivalents Utilization | 1 hour after surgery | Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams. |
| Morphine Equivalents | 12 hours after surgery | Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams. |
| DROWSINESS | 1 hour after surgery | The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy. |
| NAUSEA | 1 hour after surgery | The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous. |
| VOMITING | 6 hours after surgery | Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting. |
| PATIENT SATISFACTION | 1 hour after surgery | Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ketorolac Patients will receive Ketorolac at 5 mg/hr not to exceed 120 mg/day | 30 |
| Ketorolac With Ropivacaine Patients will receive Ketorolac and Ropivacaine 0.5% via an infusion catheter at the incision site. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 5 | 2 |
Baseline characteristics
| Characteristic | Total | Ketorolac With Ropivacaine | Ketorolac |
|---|---|---|---|
| Age | 27 years | 26 years | 27 years |
| Age, Continuous | 25 years | 25 years | 25 years |
| Pain score | 6.40 units on a scale STANDARD_DEVIATION 2.6 | 6.2 units on a scale STANDARD_DEVIATION 2.9 | 6.7 units on a scale STANDARD_DEVIATION 2.2 |
| Region of Enrollment United States | 60 Participants | 30 Participants | 30 Participants |
| Rescue analgesia utilization | 5.2 milligrams STANDARD_DEVIATION 2.8 | 4.0 milligrams STANDARD_DEVIATION 2.9 | 6.3 milligrams STANDARD_DEVIATION 1.9 |
| Sex: Female, Male Female | 60 Participants | 30 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Pain on Movement
Pain scores on movement were measured 48 hours after surgery using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 48 hours afetr surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain on Movement | 3.1 units on a scale | Standard Deviation 2.5 |
| Ketorolac With Ropivacaine | Pain on Movement | 2.5 units on a scale | Standard Deviation 1.9 |
Primary
Pain on Movement
Pain scores on movement was assessed using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain on Movement | 7.7 units on a scale | Standard Deviation 1.9 |
| Ketorolac With Ropivacaine | Pain on Movement | 7.3 units on a scale | Standard Deviation 2.9 |
Primary
Pain Score at Rest
Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: At the end of 6 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Score at Rest | 3.6 units on a scale | Standard Deviation 2.3 |
| Ketorolac With Ropivacaine | Pain Score at Rest | 4.4 units on a scale | Standard Deviation 2.5 |
Primary
Pain Score on Coughing
Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 1 hour after the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Score on Coughing | 7.6 units on a scale | Standard Deviation 2.2 |
| Ketorolac With Ropivacaine | Pain Score on Coughing | 7.5 units on a scale | Standard Deviation 2.5 |
Primary
Pain Scores at Rest
Patients report pain scores at rest using Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 1 hour after the surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores at Rest | 6.7 units on a scale | Standard Deviation 2.2 |
| Ketorolac With Ropivacaine | Pain Scores at Rest | 6.2 units on a scale | Standard Deviation 2.9 |
Primary
Pain Scores at Rest
Pain scores at rest were measured using the Visual Analog Scale (VAS) at the end of 48 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores at Rest | 1.4 units on a scale | Standard Deviation 1.6 |
| Ketorolac With Ropivacaine | Pain Scores at Rest | 1.6 units on a scale | Standard Deviation 2.1 |
Primary
Pain Scores on Coughing
Pain scores on coughing were measured using the Visual Analog Scale (VAS). This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores on Coughing | 3.4 units on a scale | Standard Deviation 2.7 |
| Ketorolac With Ropivacaine | Pain Scores on Coughing | 2.8 units on a scale | Standard Deviation 2.3 |
Primary
Pain Scores on Coughing
Pain scores on coughing were measured using the Visual Analog Scale (VAS) at the end of 6 hours after surgery. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 6 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores on Coughing | 5.3 units on a scale | Standard Deviation 2.5 |
| Ketorolac With Ropivacaine | Pain Scores on Coughing | 6.2 units on a scale | Standard Deviation 2.4 |
Primary
Pain Scores on Movement
Pain scores on movement were assessed using the Visual Analog Scale (VAS) at the end of 6 hours. This scale measures the severity of pain and ranges from 1-10, 1 being minimal pain intensity and 10 being maximal pain intensity.
Time frame: 6 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores on Movement | 5.7 units on a scale | Standard Deviation 2.3 |
| Ketorolac With Ropivacaine | Pain Scores on Movement | 26.2 units on a scale | Standard Deviation 2.7 |
Secondary
DROWSINESS
The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | DROWSINESS | 0.6 units on a scale | Standard Deviation 1.7 |
| Ketorolac With Ropivacaine | DROWSINESS | 0.1 units on a scale | Standard Deviation 0.4 |
Secondary
DROWSINESS
The severity of drowsiness was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally drowsy and 10 meaning maximally drowsy.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | DROWSINESS | 4 units on a scale | Standard Deviation 2.7 |
| Ketorolac With Ropivacaine | DROWSINESS | 4.4 units on a scale | Standard Deviation 2.7 |
Secondary
Morphine Equivalents
Utilization of morphine and morphine equivalents for rescue analgesia was reviewed and calculated in milligrams.
Time frame: 12 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Morphine Equivalents | 2.1 milligrams | Standard Deviation 1.4 |
| Ketorolac With Ropivacaine | Morphine Equivalents | 1.5 milligrams | Standard Deviation 1.1 |
Secondary
Morphine Equivalents
Utilization of morphine and morphine equivalents for rescue analgesia, was reviewed and calculated in milligrams.
Time frame: 48 hours afetr surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Morphine Equivalents | 4.2 milligrams | Standard Deviation 2.5 |
| Ketorolac With Ropivacaine | Morphine Equivalents | 4.6 milligrams | Standard Deviation 1.9 |
Secondary
Morphine Equivalents Utilization
Utilization of morphine and morpine equivalents for rescue analgesia was reviewed and calculated in milligrams.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Morphine Equivalents Utilization | 6.3 miliigrams | Standard Deviation 1.9 |
| Ketorolac With Ropivacaine | Morphine Equivalents Utilization | 4 miliigrams | Standard Deviation 2.9 |
Secondary
NAUSEA
The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous.
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | NAUSEA | 0.3 units on a scale | Standard Deviation 0.9 |
| Ketorolac With Ropivacaine | NAUSEA | 0.4 units on a scale | Standard Deviation 1.8 |
Secondary
NAUSEA
The severity of nausea was measured using Visual Analog Scale (VAS). The VAS scale ranges from 1-10, 1 meaning minimally nauseous and 10 meaning maximally nauseous.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | NAUSEA | 0.6 units on a scale | Standard Deviation 1.6 |
| Ketorolac With Ropivacaine | NAUSEA | 0.9 units on a scale | Standard Deviation 2 |
Secondary
PATIENT SATISFACTION
Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | PATIENT SATISFACTION | 5.4 units on a scale | Standard Deviation 2.6 |
| Ketorolac With Ropivacaine | PATIENT SATISFACTION | 4.9 units on a scale | Standard Deviation 2.8 |
Secondary
PATIENT SATISFACTION
Patient's overall satisfaction was measured using Visual Analog Scale (VAS). This scale ranges from 1-10, 1 indicating least satisfied and 10 indication very well satisfied.
Time frame: 48 hours afetr surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | PATIENT SATISFACTION | 8.5 units on a scale | Standard Deviation 1.4 |
| Ketorolac With Ropivacaine | PATIENT SATISFACTION | 8.5 units on a scale | Standard Deviation 1.6 |
Secondary
VOMITING
Data on number of episodes of vomiting was obtained, 6 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.
Time frame: 6 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | VOMITING | 0.2 EPISODES | Standard Deviation 0.6 |
| Ketorolac With Ropivacaine | VOMITING | 0.1 EPISODES | Standard Deviation 0.3 |
Secondary
VOMITING
Data on number of episodes of vomiting was obtained, 12 hours after the surgery. The number of episodes were reported in numerical values, the lower numbers indicating fewer episodes and the higher numbers indicating more number of episodes of vomiting.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | VOMITING | 0 EPISODES | Standard Deviation 0 |
| Ketorolac With Ropivacaine | VOMITING | 0 EPISODES | Standard Deviation 0 |