Laparoscopic Colorectal Resection
Conditions
Keywords
TAP block, Paravertebral block, Epidural, Laparoscopic colectomy
Brief summary
The purpose of this study is to assess the effectiveness of transversus abdominal plane (TAP) block, thoracic epidural or paravertebral block (PVB) for controlling postoperative pain when compared with opioid you self-administer in your vein using a PCA device. The primary outcome will be postoperative opioid consumption within 24 hours after surgery. A total of 120 subjects will be randomized in a 1:1:1:1 ratio to receive a TAP block, PVB, TEA or no block (PCA alone).Patients in all groups will be cared for using an established enhanced recovery after surgery (ERAS) pathway incorporating a multimodal analgesic regimen using IV acetaminophen and postoperative PCA fentanyl.
Interventions
PROCEDURETAP block
PROCEDUREEpidural
PROCEDUREParavertebral block
DRUGAcetaminophen 1g IV
DRUGDexamethasone 4mg
DRUGMidazolam up to 2mg
DRUGPropofol 1-2.5 mg/kg
DRUGSevoflurane to keep a bispectral index of between 40-60
DRUGLocal infiltration with 10 mL of plain ropivacaine 0.25%
DRUGLidocaine
1.5% lidocaine
DRUGEpinephrine
1:200,000 epinephrine
DRUGHydromorphone
400-800 mcg Hydromorphone will be given preoperatively
Sponsors
Duke University
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
* Male or female, ≥ 18 years of age * Patients scheduled to undergo laparoscopic colectomy without stoma under general anesthesia * American Society of Anesthesiology (ASA) Physical Class 1-3.
Exclusion criteria
* Open colectomy * Perineal resection * Stoma formation * Patients with a contraindication to TEA or regional anesthesia. * Pregnancy, nursing, or planning to become pregnant during the study or within one month. * Long-acting opioid medication within 3 days. * Any opioid medication within 24 hours. * Body weight less than 50 kilograms (\ 110 pounds) * Uncontrolled anxiety, schizophrenia, or other psychiatric disorder * Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may increase the risk of surgery or complicate the subject's postoperative course. * Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study. * Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. * Significant medical conditions or laboratory results that, in the opinion of the Investigator, indicate an increased vulnerability to study drugs and procedures, and expose the subject to an unreasonable risk as a result of participating in this clinical trial, such as: debilitating diseases, acute illnesses, hypotension, partial or complete conduction block, impaired cardiac function, untreated hypertension, advanced arteriosclerotic heart disease, cerebral vascular insufficiency, pre-existing abnormal neurological or neuromuscular disease (e.g., epilepsy, myasthenia gravis), advanced liver disease, severe renal impairment, advanced diabetes, comorbid conditions associated with an immunocompromised status, such as blood dyscrasias, HIV/AIDS, or recent chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Consumption | 24 hours after surgery | If opioid other than fentanyl is used, the dose will be converted to morphine equivalent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery | 72 hours | Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged. |
| Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS) | Participants will be followed for the duration of hospital stay, an estimated 1 week | Complications using a Modified Postoperative Morbidity Survey (MPMS) |
| Time to First Bowel Movement | Participants will be followed for the duration of hospital stay, an estimated 1 week | — |
| Pain Scores | Participants will be followed for the duration of hospital stay, an estimated 1 week | Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated. |
| Time to First Ingestion of Solid Food | Participants will be followed for the duration of hospital stay, an estimated 1 week | — |
| Number of Epidural-related Side Effects | Participants will be followed for the duration of hospital stay, an estimated 1 week | — |
| Length of Stay | Participants will be followed for the duration of hospital stay, an estimated 1 week | — |
| Opioid Related Side Effects | Participants will be followed for the duration of hospital stay, an estimated 1 week | Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points. |
Countries
United States
Participant flow
Pre-assignment details
Of the 17 patients that consented, one patient withdrew before randomization
Participants by arm
| Arm | Count |
|---|---|
| Paravertebral Block Bilateral PVB will be placed between T7-T10 interspaces preoperatively. Patients will be in a sitting position which allows easy identification of landmarks, and the patients are often more comfortable. Ultrasound will be used to identify the paravertebral space. At the appropriate dermatome under aseptic precautions, the needle (22-gauge, 8-10-cm short beveled spinal needle) will inserted 2.5-3 cm lateral to the most cephalad aspect of the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process 3 of the vertebra below at a variable depth (2-4 cm). A 10 mL ropivacaine 0.25% will be injected at both T7 and T9 levels on each side (40 mL in total).
Paravertebral block
Acetaminophen 1g IV
Dexamethasone 4mg
Midazolam up to 2mg
Propofol 1-2.5 mg/kg
Sevoflurane to keep a bispectral index of between 40-60
Local infiltration with 10 mL of plain ropivacaine 0.25% | 4 |
| TAP Block Bilateral posterior and subcostal TAP blocks guided by ultrasound will be performed in the preoperative holding area. A total of 80 mL ropivacaine 0.25% (4 injections, 20 mL per injection) will be injected evenly upon identification of the appropriate planes. In the event the placement of block is uncomfortable for the patients, it will be performed after induction of anesthesia. This approach is currently practiced in the OR. Extent and degree of anesthetic blockage will be measured using a 5-point sensation scale following the procedure at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).
TAP block
Acetaminophen 1g IV
Dexamethasone 4mg
Midazolam up to 2mg
Propofol 1-2.5 mg/kg
Sevoflurane to keep a bispectral index of between 40-60
Local infiltration with 10 mL of plain ropivacaine 0.25% | 3 |
| Epidural An epidural catheter will be inserted between T8-10 in the preoperative holding area, and a test dose of 1.5% lidocaine with 1:200,000 epinephrine will be given. Extent and degree of anesthetic blockage will be measured using a 5-point sensation following the procedure and postoperatively at 4 areas on the anterior abdominal wall (above and below the umbilicus bilaterally).
A bolus does of epidural hydromorphone (400-800 mcg) will be given preoperatively. An infusion of bupivacaine 0.25% at 4-6 ml/hour will be commenced before incision, and if tolerated, continued throughout surgery. Adjustments that may be required secondary to specific patient hemodynamic status will be left to the discretion of the individual anesthesiologist and guided by the specific patient requirements.
Epidural
Acetaminophen 1g IV
Dexamethasone 4mg
Midazolam up to 2mg
Propofol 1-2.5 mg/kg
Sevoflurane to keep a bispectral index of between 40-60
Local infiltration with 10 mL of plain ropi | 4 |
| No Block (PCA Alone) Premedication with midazolam up to 2 mg. General anesthesia is induced with propofol 1-2.5 mg/kg. Dexamethasone 4 mg IV will be administered after induction of anesthesia. Anesthesia will be maintained with sevoflurane to keep a bispectral index of between 40-60. Neuromuscular blocking drug and reversal agent of choice may be used. Local infiltration with 10 mL of plain ropivacaine 0.25% will be administered at the surgical incision site at the end of surgery. Acetaminophen 1g IV will be administered following induction of anesthesia will be administered at the end of the procedure
Acetaminophen 1g IV
Dexamethasone 4mg
Midazolam up to 2mg
Propofol 1-2.5 mg/kg
Sevoflurane to keep a bispectral index of between 40-60
Local infiltration with 10 mL of plain ropivacaine 0.25% | 4 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Converted to open procedure | 1 | 0 | 0 | 2 |
| Overall Study | Failed regional block | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Paravertebral Block | TAP Block | Epidural | No Block (PCA Alone) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55.5 years STANDARD_DEVIATION 8.5 | 51 years STANDARD_DEVIATION 15 | 57.75 years STANDARD_DEVIATION 6.6 | 52 years STANDARD_DEVIATION 21.9 | 54.2 years STANDARD_DEVIATION 12.9 |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 2 Participants | 2 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Postoperative Opioid Consumption
If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
Time frame: 24 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Postoperative Opioid Consumption | 734 mcg | Standard Deviation 422 |
| TAP Block | Postoperative Opioid Consumption | 666 mcg | Standard Deviation 474 |
| Epidural | Postoperative Opioid Consumption | 125 mcg | Standard Deviation 50 |
| No Block (PCA Alone) | Postoperative Opioid Consumption | 1017.5 mcg | Standard Deviation 484 |
Secondary
Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
Complications using a Modified Postoperative Morbidity Survey (MPMS)
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Population: Data not collected
Secondary
Length of Stay
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Length of Stay | 2.66 Days | Standard Deviation 0.57 |
| TAP Block | Length of Stay | 4.33 Days | Standard Deviation 3.21 |
| Epidural | Length of Stay | 4 Days | Standard Deviation 1.41 |
| No Block (PCA Alone) | Length of Stay | 3.5 Days | Standard Deviation 0.7 |
Secondary
Number of Epidural-related Side Effects
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paravertebral Block | Number of Epidural-related Side Effects | 0 Number of side effects |
| TAP Block | Number of Epidural-related Side Effects | 0 Number of side effects |
| Epidural | Number of Epidural-related Side Effects | 0 Number of side effects |
| No Block (PCA Alone) | Number of Epidural-related Side Effects | 0 Number of side effects |
Secondary
Opioid Related Side Effects
Occurrence and duration of opioid related adverse events including postoperative nausea and vomiting (PONV); pruritus, urinary retention, confusion, sedation and respiratory depression at the above time points.
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paravertebral Block | Opioid Related Side Effects | 0 side effects |
| TAP Block | Opioid Related Side Effects | 0 side effects |
| Epidural | Opioid Related Side Effects | 0 side effects |
| No Block (PCA Alone) | Opioid Related Side Effects | 0 side effects |
Secondary
Pain Scores
Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever, at 30, 60, 90, 120 min and every 6 hours for 24 hours and every 12 hours for 48 hours and once a day thereafter until discharge. Data were collected at the indicated time points and an average pain score was calculated.
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Pain Scores | 4.66 Units on a scale | Standard Deviation 1.15 |
| TAP Block | Pain Scores | 2.66 Units on a scale | Standard Deviation 1.52 |
| Epidural | Pain Scores | 1.75 Units on a scale | Standard Deviation 1.25 |
| No Block (PCA Alone) | Pain Scores | 6 Units on a scale | Standard Deviation 2.82 |
Secondary
Quality of Recovery
Quality of Recovery Score (QoR-15) is measured on a scale of 0-150 (0=poor, 150 = excellent). Scores were collected daily for 72 hours and then averaged.
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Quality of Recovery | 89.5 Units on a scale | Standard Deviation 10.6 |
| TAP Block | Quality of Recovery | 117 Units on a scale | Standard Deviation 23.3 |
| Epidural | Quality of Recovery | 115.5 Units on a scale | Standard Deviation 0.7 |
| No Block (PCA Alone) | Quality of Recovery | 99 Units on a scale | Standard Deviation 17.6 |
Secondary
Time to First Bowel Movement
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Time to First Bowel Movement | 1 days | Standard Deviation 1.4 |
| TAP Block | Time to First Bowel Movement | 2 days | Standard Deviation 0.7 |
| Epidural | Time to First Bowel Movement | 1 days | Standard Deviation 0.8 |
| No Block (PCA Alone) | Time to First Bowel Movement | 2 days | Standard Deviation 0 |
Secondary
Time to First Ingestion of Solid Food
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paravertebral Block | Time to First Ingestion of Solid Food | 1 Days | Standard Deviation 0 |
| TAP Block | Time to First Ingestion of Solid Food | 2 Days | Standard Deviation 0.7 |
| Epidural | Time to First Ingestion of Solid Food | 0.75 Days | Standard Deviation 0.5 |
| No Block (PCA Alone) | Time to First Ingestion of Solid Food | 1.5 Days | Standard Deviation 0.7 |