Laparoscopic Colorectal Resection Clinical Trial
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
| Verified date | January 2017 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 17 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Postoperative Opioid Consumption | If opioid other than fentanyl is used, the dose will be converted to morphine equivalent. | 24 hours after surgery | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Time to First Bowel Movement | Participants will be followed for the duration of hospital stay, an estimated 1 week | ||
| Secondary | 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 | |
| Secondary | Time to First Ingestion of Solid Food | Participants will be followed for the duration of hospital stay, an estimated 1 week | ||
| Secondary | Number of Epidural-related Side Effects | Participants will be followed for the duration of hospital stay, an estimated 1 week | ||
| Secondary | Length of Stay | Participants will be followed for the duration of hospital stay, an estimated 1 week |