OFA - Opioid Free Anesthesia
OFA
Study Protocol "OFA: Opioid-Free Anesthesia".
1 other identifier
interventional
64
1 country
1
Brief Summary
Opioids have been used for analgesia since many years, but despite potent analgesia they are also associated to side effects, including opioid induced Hyperalgesia (OIH). OIH in the surgical setting is debated, and may predispose patients to higher analgesic consumption in the preoperative period, and peripheral and central sensitization. The aim of the study is to compare remifentanil-based vs non opioid analgesia (clonidine, lidocaine, ketamine) for intraoperative management of patients undergoing laparoscopic left hemicolectomy, with the hypothesis that non- opiod treated patients will have lower morphine consumption in the first 24 hours after surgery. Peripheral and central hyperalgesia will be tested with Von Frey hairs and pin-prick to evaluate acute CNS (Central Nervous System) sensitization after surgery. Acute and persistent (1 and 3 months) pain will be registered, together with any side effect and parameters of surgical rehabilitation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 postoperative-pain
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2017
CompletedFirst Submitted
Initial submission to the registry
January 22, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedApril 21, 2017
April 1, 2017
12 months
January 22, 2017
April 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
analgesic consumption
morphine mg by PCA (Patient Controlled Analgesia)
24 HOURS
Secondary Outcomes (4)
side effects
4 days after surgery
Pain Score on the Visual Analog Scale
3 months
peripheral sensitization
24 hours
central sensitization
24 hours
Study Arms (2)
opioid
ACTIVE COMPARATORremifentanil 0,15-0,25 mcg/kg/h
opioid free
EXPERIMENTALketamine bolus 0,5 mg/kg + infusion 0,25 mg/kg/h lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h clonidine 4 mcg/kg
Interventions
Eligibility Criteria
You may qualify if:
- left hemicolectomy
- signed informed consent
- \>18 ys
You may not qualify if:
- \>90 ys \<18 ys
- no consent
- pregnancy
- psychiatric disease
- cardiac failure, aortic or mitral valve severe stenosis
- kidney or hepatic failure
- atrio-ventricular type II block
- immunodepression
- emergency surgery
- ICU admittance
- drug or alcohol abuse
- chronic pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Parma, Parma, 43100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Assistant Professor
Study Record Dates
First Submitted
January 22, 2017
First Posted
April 21, 2017
Study Start
January 4, 2017
Primary Completion
December 31, 2017
Study Completion
March 31, 2018
Last Updated
April 21, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share