Clinical trial NCT02164929: Comparison Study of Transversus Abdominal Plane, Paravertebral and Epidural Blocks in Laparoscopic Colectomy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Laparoscopic Colorectal Resection
Keywords: TAP block
Paravertebral block
Epidural
Laparoscopic colectomy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-06-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Postoperative Opioid Consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Pain Scores
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Quality of Recovery
timeFrame: 72 hours
measure: Complications as Measured by a Modified Postoperative Morbidity Survey (MPMS)
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Time to First Bowel Movement
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Opioid Related Side Effects
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Time to First Ingestion of Solid Food
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Number of Epidural-related Side Effects
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
measure: Length of Stay
timeFrame: Participants will be followed for the duration of hospital stay, an estimated 1 week
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References: