Laparoscopic Colorectal ResectionNCT02164929
Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy
A study testing TAP block, Epidural and Paravertebral block in people with Laparoscopic Colorectal Resection, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colorectal Resection
- What is being tested?
- TAP block, Epidural and Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy
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.
- Conditions
- Laparoscopic Colorectal Resection
- Being tested
- TAP block, Epidural, Paravertebral block, Acetaminophen 1g IV, Dexamethasone 4mg
- Keywords
- TAP block, Paravertebral block, Epidural, Laparoscopic colectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Also called Transversus abdominus plane block
EpiduralProcedure or surgery
Also called Thoracic Epidural Anesthesia (TEA)
Paravertebral blockProcedure or surgery
Also called PVB
Acetaminophen 1g IVDrug
Dexamethasone 4mgDrug
Midazolam up to 2mgDrug
Propofol 1-2.5 mg/kgDrug
Sevoflurane to keep a bispectral index of between 40-60Drug
Local infiltration with 10 mL of plain ropivacaine 0.25%Drug
LidocaineDrug
1.5% lidocaine
EpinephrineDrug
1:200,000 epinephrine
HydromorphoneDrug
400-800 mcg Hydromorphone will be given preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block | Active comparator | 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). Receives: Procedure: Paravertebral block; Drug: Acetaminophen 1g IV; Drug: Dexamethasone 4mg; Drug: Midazolam up to 2mg; Drug: Propofol 1-2.5 mg/kg; Drug: Sevoflurane to keep a bispectral index of between 40-60; Drug: Local infiltration with 10 mL of plain ropivacaine 0.25% |
| TAP block | Active comparator | 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). Receives: Procedure: TAP block; Drug: Acetaminophen 1g IV; Drug: Dexamethasone 4mg; Drug: Midazolam up to 2mg; Drug: Propofol 1-2.5 mg/kg; Drug: Sevoflurane to keep a bispectral index of between 40-60; Drug: Local infiltration with 10 mL of plain ropivacaine 0.25% |
| Epidural | Active comparator | 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. Receives: Procedure: Epidural; Drug: Acetaminophen 1g IV; Drug: Dexamethasone 4mg; Drug: Midazolam up to 2mg; Drug: Propofol 1-2.5 mg/kg; Drug: Sevoflurane to keep a bispectral index of between 40-60; Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%; Drug: Lidocaine; Drug: Epinephrine; Drug: Hydromorphone |
| No block (PCA alone) | Active comparator | 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 Receives: Drug: Acetaminophen 1g IV; Drug: Dexamethasone 4mg; Drug: Midazolam up to 2mg; Drug: Propofol 1-2.5 mg/kg; Drug: Sevoflurane to keep a bispectral index of between 40-60; Drug: Local infiltration with 10 mL of plain ropivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption
If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
Measured: 24 hours after surgery
Secondary outcomes (8)
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.
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
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.
Measured: 72 hours
Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
Complications using a Modified Postoperative Morbidity Survey (MPMS)
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
Time to First Bowel Movement
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
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.
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
Time to First Ingestion of Solid Food
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
Number of Epidural-related Side Effects
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
Length of Stay
Measured: Participants will be followed for the duration of hospital stay, an estimated 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Laparoscopic Colorectal ResectionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164929
- Sponsor's protocol ID
- Pro00047810
- Status last verified
- Jan 2017
- First submitted
- 11 Jun 2014
- Last updated
- 25 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Single-Blind Study to Evaluate the Efficacy of Transversus Abdominis Plane Versus Paravertebral Regional Blockade in Patients Undergoing Laparoscopic Colectomy
- ClinicalTrials.gov ID
- NCT02164929
- Acronym / sponsor ID
- Pro00047810
- Conditions
- Laparoscopic Colorectal Resection
- Keywords
- TAP block, Paravertebral block, Epidural, Laparoscopic colectomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Posted 25 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block | Active comparator | Procedure: Paravertebral block, Drug: Acetaminophen 1g IV, Drug: Dexamethasone 4mg, Drug: Midazolam up to 2mg, Drug: Propofol 1-2.5 mg/kg, Drug: Sevoflurane to keep a bispectral index of between 40-60, Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%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). |
| TAP block | Active comparator | Procedure: TAP block, Drug: Acetaminophen 1g IV, Drug: Dexamethasone 4mg, Drug: Midazolam up to 2mg, Drug: Propofol 1-2.5 mg/kg, Drug: Sevoflurane to keep a bispectral index of between 40-60, Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%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). |
| Epidural | Active comparator | Procedure: Epidural, Drug: Acetaminophen 1g IV, Drug: Dexamethasone 4mg, Drug: Midazolam up to 2mg, Drug: Propofol 1-2.5 mg/kg, Drug: Sevoflurane to keep a bispectral index of between 40-60, Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%, Drug: Lidocaine, Drug: Epinephrine, Drug: HydromorphoneAn 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. |
| No block (PCA alone) | Active comparator | Drug: Acetaminophen 1g IV, Drug: Dexamethasone 4mg, Drug: Midazolam up to 2mg, Drug: Propofol 1-2.5 mg/kg, Drug: Sevoflurane to keep a bispectral index of between 40-60, Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP blockAlso: Transversus abdominus plane block | Procedure or surgery | TAP block |
| EpiduralAlso: Thoracic Epidural Anesthesia (TEA) | Procedure or surgery | Epidural |
| Paravertebral blockAlso: PVB | Procedure or surgery | Paravertebral block |
| Acetaminophen 1g IV | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Dexamethasone 4mg | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Midazolam up to 2mg | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Propofol 1-2.5 mg/kg | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Sevoflurane to keep a bispectral index of between 40-60 | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Local infiltration with 10 mL of plain ropivacaine 0.25% | Drug | Epidural, No block (PCA alone), Paravertebral block, TAP block |
| Lidocaine1.5% lidocaine | Drug | Epidural |
| Epinephrine1:200,000 epinephrine | Drug | Epidural |
| Hydromorphone400-800 mcg Hydromorphone will be given preoperatively | Drug | Epidural |
Primary outcome
Postoperative Opioid Consumption
Time frame: 24 hours after surgery
If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.
8 secondary outcomes
Pain Scores
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Quality of Recovery
Time frame: 72 hours
Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Time to First Bowel Movement
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Opioid Related Side Effects
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Time to First Ingestion of Solid Food
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Number of Epidural-related Side Effects
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Length of Stay
Time frame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block, Epidural and Paravertebral block in people with Laparoscopic Colorectal Resection, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Opioid Consumption (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.