Nausea, Pain
Conditions
Keywords
Inguinal Herniorrhaphy, Pain assessment, Outcomes
Brief summary
The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.
Detailed description
Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments
Interventions
DRUGropivacaine
10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation
DRUGLidocaine/Ketamine
Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).
OTHERplacebo
placebo
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age greater than 18 and less than 75 years * Male * Unilateral inguinal hernia scheduled for elective open repair
Exclusion criteria
* Incarcerated hernia or urgent procedure * Reoperation (recurrent hernia) * Contraindication to regional anesthesia such as: * Coagulopathy * Infection at the site of needle insertion * Pre-existing chronic pain (at any site) requiring treatment * Contraindication to any study medication (local anesthetic or ketamine) * History of significant Axis I psychiatric disease (major depressive disorder,bipolar disorder, schizophrenia, etc.) * Significant hepatic (ALT or AST \> 2 times normal) or renal (serum creatinine \> 2 mg/dl) impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption in Oral Oxycodone Equivalents | 2 days after surgery | The cumulative opioid consumption after surgery until the end of second postoperative day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | From admission to the end of surgery | The cumulative opioid consumption is calculated as fentanyl equivalent |
| Time From the End of Surgery to Readiness for Hospital Discharge. | Until hospital discharge, assessed up to 6 months | — |
| Pain Scores on Numerical Rating Scale | After surgery until the second postoperative mornings. | Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings. |
| Postoperative Nausea | After surgery until the second postoperative day. | Number of patients who had postoperative nausea or vomiting were recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation
ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation | 5 |
| Lidocaine/Ketamine Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.
Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg). | 4 |
| Placebo General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
placebo: placebo | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Lidocaine/Ketamine | Ropivacaine | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 52 years STANDARD_DEVIATION 10 | 48 years STANDARD_DEVIATION 12 | 53 years STANDARD_DEVIATION 13 | 50 years STANDARD_DEVIATION 11 |
| Height | 183 cm STANDARD_DEVIATION 5 | 176 cm STANDARD_DEVIATION 10 | 179 cm STANDARD_DEVIATION 13 | 179 cm STANDARD_DEVIATION 7 |
| 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 | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 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 | 4 Participants | 5 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 3 Participants | 12 Participants |
| Weight | 77 kg STANDARD_DEVIATION 14 | 90 kg STANDARD_DEVIATION 13 | 101 kg STANDARD_DEVIATION 13 | 88 kg STANDARD_DEVIATION 15 |
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 / 3 |
| other Total, other adverse events | 0 / 5 | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 4 | 0 / 3 |
Outcome results
Primary
Postoperative Opioid Consumption in Oral Oxycodone Equivalents
The cumulative opioid consumption after surgery until the end of second postoperative day.
Time frame: 2 days after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ropivacaine | Postoperative Opioid Consumption in Oral Oxycodone Equivalents | 564 mg |
| Lidocaine/Ketamine | Postoperative Opioid Consumption in Oral Oxycodone Equivalents | 73 mg |
| Placebo | Postoperative Opioid Consumption in Oral Oxycodone Equivalents | 1381 mg |
Secondary
Pain Scores on Numerical Rating Scale
Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.
Time frame: After surgery until the second postoperative mornings.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine | Pain Scores on Numerical Rating Scale | POD1 | 4.6 units on a scale | Standard Deviation 1.9 |
| Ropivacaine | Pain Scores on Numerical Rating Scale | PACU | 0.8 units on a scale | Standard Deviation 1.8 |
| Ropivacaine | Pain Scores on Numerical Rating Scale | POD2 | 2.6 units on a scale | Standard Deviation 0.5 |
| Lidocaine/Ketamine | Pain Scores on Numerical Rating Scale | POD1 | 3.3 units on a scale | Standard Deviation 1.9 |
| Lidocaine/Ketamine | Pain Scores on Numerical Rating Scale | PACU | 2.0 units on a scale | Standard Deviation 4 |
| Lidocaine/Ketamine | Pain Scores on Numerical Rating Scale | POD2 | 2.8 units on a scale | Standard Deviation 1.3 |
| Placebo | Pain Scores on Numerical Rating Scale | PACU | 6.3 units on a scale | Standard Deviation 1.5 |
| Placebo | Pain Scores on Numerical Rating Scale | POD2 | 2 units on a scale | Standard Deviation 1 |
| Placebo | Pain Scores on Numerical Rating Scale | POD1 | 3.7 units on a scale | Standard Deviation 2.1 |
Secondary
Postoperative Nausea
Number of patients who had postoperative nausea or vomiting were recorded.
Time frame: After surgery until the second postoperative day.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ropivacaine | Postoperative Nausea | 2 Participants |
| Lidocaine/Ketamine | Postoperative Nausea | 1 Participants |
| Placebo | Postoperative Nausea | 0 Participants |
Secondary
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
The cumulative opioid consumption is calculated as fentanyl equivalent
Time frame: From admission to the end of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | 100 mcg | Standard Deviation 50 |
| Lidocaine/Ketamine | Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | 113 mcg | Standard Deviation 25 |
| Placebo | Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | 134 mcg | Standard Deviation 58 |
Secondary
Time From the End of Surgery to Readiness for Hospital Discharge.
Time frame: Until hospital discharge, assessed up to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine | Time From the End of Surgery to Readiness for Hospital Discharge. | 2.2 hours | Standard Deviation 0.3 |
| Lidocaine/Ketamine | Time From the End of Surgery to Readiness for Hospital Discharge. | 3.8 hours | Standard Deviation 1 |
| Placebo | Time From the End of Surgery to Readiness for Hospital Discharge. | 3.0 hours | Standard Deviation 0.3 |