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

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.

Study Overview

• Status: Terminated
• Conditions: Laparoscopic Colorectal Resection
• Intervention / Treatment: Procedure: Epidural; 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%; Procedure: TAP block; Drug: Lidocaine; Drug: Epinephrine; Drug: Hydromorphone

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Procedure: Paravertebral block; Other Names: PVB; 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%
Active Comparator: 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).	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%; Procedure: TAP block; Other Names: Transversus abdominus plane block
Active Comparator: 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.	Procedure: Epidural; Other Names: Thoracic Epidural Anesthesia (TEA); 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; 1.5% lidocaine; Drug: Epinephrine; 1:200,000 epinephrine; Drug: Hydromorphone; 400-800 mcg Hydromorphone will be given preoperatively
Active Comparator: 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	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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Opioid Consumption	If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	72 hours
Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)	Complications using 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	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.	Participants will be followed for the duration of hospital stay, an estimated 1 week
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

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): September 25, 2017
• Last Update Submitted That Met QC Criteria: August 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Epidural; TAP block; Paravertebral block; Laparoscopic colectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Platelet Aggregation Inhibitors; Antipyretics; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Tranquilizing Agents; Psychotropic Drugs; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anesthetics, Inhalation; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Dexamethasone; Midazolam; Propofol; Lidocaine; Acetaminophen; Sevoflurane; Ropivacaine; Epinephrine; Hydromorphone
• Other Study ID Numbers: Pro00047810