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

Duke University

Status: Terminated

Conditions: Laparoscopic Colorectal Resection

Treatments: Drug: Propofol 1-2.5 mg/kg; Procedure: Paravertebral block; Drug: Sevoflurane to keep a bispectral index of between 40-60; Drug: Dexamethasone 4mg; Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%; Drug: Acetaminophen 1g IV; Procedure: Epidural; Drug: Hydromorphone; Drug: Lidocaine; Drug: Midazolam up to 2mg; Drug: Epinephrine; Procedure: TAP block

Study type: Interventional

Funder types: Other

Identifiers

NCT02164929

Pro00047810

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 4 patient groups

Paravertebral block

Active Comparator group

Description:

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).

Treatment:

Drug: Propofol 1-2.5 mg/kg

Drug: Acetaminophen 1g IV

Drug: Sevoflurane to keep a bispectral index of between 40-60

Drug: Midazolam up to 2mg

Procedure: Paravertebral block

Drug: Dexamethasone 4mg

Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

TAP block

Active Comparator group

Description:

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).

Treatment:

Procedure: TAP block

Drug: Propofol 1-2.5 mg/kg

Drug: Acetaminophen 1g IV

Drug: Sevoflurane to keep a bispectral index of between 40-60

Drug: Midazolam up to 2mg

Drug: Dexamethasone 4mg

Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

Epidural

Active Comparator group

Description:

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.

Treatment:

Drug: Hydromorphone

Drug: Propofol 1-2.5 mg/kg

Drug: Acetaminophen 1g IV

Drug: Sevoflurane to keep a bispectral index of between 40-60

Drug: Midazolam up to 2mg

Drug: Lidocaine

Drug: Epinephrine

Drug: Dexamethasone 4mg

Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%

Procedure: Epidural

No block (PCA alone)

Active Comparator group

Description:

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

Treatment:

Drug: Propofol 1-2.5 mg/kg

Drug: Acetaminophen 1g IV

Drug: Sevoflurane to keep a bispectral index of between 40-60

Drug: Midazolam up to 2mg

Drug: Dexamethasone 4mg

Drug: Local infiltration with 10 mL of plain ropivacaine 0.25%