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

• ClinicalTrials.gov Identifier: NCT02164929
• Recruitment Status: Terminated
• First Posted: June 17, 2014
• Results First Posted: September 25, 2017
• Last Update Posted: September 25, 2017
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Laparoscopic Colorectal Resection	Procedure: TAP block; 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%; Drug: Lidocaine; Drug: Epinephrine; Drug: Hydromorphone	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 17 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2013
• Actual Primary Completion Date: March 2015
• Actual Study Completion Date: March 2015

Arms and Interventions

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 Name: 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).	Procedure: TAP block; Other Name: Transversus abdominus plane 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%
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 Name: 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%

Outcome Measures

Primary Outcome Measures :

1. Postoperative Opioid Consumption [ Time Frame: 24 hours after surgery ]
   If opioid other than fentanyl is used, the dose will be converted to morphine equivalent.

Secondary Outcome Measures :

1. Pain Scores [ Time Frame: 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.
2. Quality of Recovery [ Time Frame: 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.
3. 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 ]
   Complications using a Modified Postoperative Morbidity Survey (MPMS)
4. Time to First Bowel Movement [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
5. Opioid Related Side Effects [ Time Frame: 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.
6. Time to First Ingestion of Solid Food [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
7. Number of Epidural-related Side Effects [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]
8. Length of Stay [ Time Frame: Participants will be followed for the duration of hospital stay, an estimated 1 week ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, North Carolina

Duke University Medical Center

Durham, North Carolina, United States, 27701

Sponsors and Collaborators

Duke University

More Information

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02164929
• Other Study ID Numbers: Pro00047810
• First Posted: June 17, 2014
• Results First Posted: September 25, 2017
• Last Update Posted: September 25, 2017
• Last Verified: January 2017

Keywords provided by Duke University:

TAP block; Paravertebral block; Epidural; Laparoscopic colectomy

Additional relevant MeSH terms:

Acetaminophen; Dexamethasone; Lidocaine; Epinephrine; Midazolam; Hydromorphone; Ropivacaine; Propofol; Sevoflurane; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Hypnotics and Sedatives