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Multi-Drug Analgesia vs. Standard Solution for Anal Surgery

NCT03105674 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-07-25

No results posted yet for this study

Summary

The primary aim is to test the magnitude and duration of analgesia provided by single dose multi-drug analgesia administered for perianal block, and compare with standard solution (Marcaine \& Lidocaine in 1:1 mixture - Total 60 ml), at post-operative period and also to compare with the standard solution including their respective post-operative opioid or non-opioid oral analgesic requirement. Local anesthesia via a perianal block using multi-drug analgesia or standard solution will be compared using the Numeric pain rating scale on Post-operative day 1, 3 and during follow up visit on day 7. The investigators hope to find a better control of post-operative analgesia which will lead to better functional outcomes. Possible decrease consumption of opioids in the post-operative period will perhaps decrease the cost and chances of addiction and will increase patient comfort and compliance.

Conditions

Interventions

DRUG

Multi-drug local anesthetics (Combination)

1. Ropivacaine 0.5% - 30 ml 2. Ketorolac 30mg/ml - 1 ml 3. Kenalog 10 mg/ml - 5 ml 4. Lidocaine 1% with Epinephrine 1:100,000 - 20ml

DRUG

Standard local anesthetics (Combination)

Marcaine and Lidocaine

Sponsors & Collaborators

Principal Investigators

  • Emmanouil Pappou, MD, PhD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2017-11-30
Completion
2017-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03105674 on ClinicalTrials.gov