Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy

NCT02164929 | Terminated Results

• 1 other identifier: Pro00047810
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Colorectal Resection

Keywords

TAP block; Paravertebral block; Epidural; Laparoscopic colectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Consumption

  If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.

  24 hours after surgery

Secondary Outcomes (8)

• Pain Scores

  Participants will be followed for the duration of hospital stay, an estimated 1 week

• Quality of Recovery

  72 hours

• Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)

  Participants will be followed for the duration of hospital stay, an estimated 1 week

• Time to First Bowel Movement

  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

Study Arms (4)

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).

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).

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.

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

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%

Interventions

TAP block PROCEDURE

Also known as: Transversus abdominus plane block

TAP block

Epidural PROCEDURE

Also known as: Thoracic Epidural Anesthesia (TEA)

Epidural

Paravertebral block PROCEDURE

Also known as: PVB

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

Lidocaine DRUG

1.5% lidocaine

Epidural

Epinephrine DRUG

1:200,000 epinephrine

Epidural

Hydromorphone DRUG

400-800 mcg Hydromorphone will be given preoperatively

Epidural

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Interventions

Injections, Epidural; Acetaminophen; Dexamethasone; Propofol; Lidocaine; Epinephrine; Hydromorphone

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Results Point of Contact

• Title: Timothy Miller, MD
• Organization: Duke University Medical Center

timothy.miller2@duke.edu

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 17, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 25, 2017
• Results First Posted: September 25, 2017

Record last verified: 2017-01

Locations

US (1)