Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy volunteers and in animal models. Is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli. The apparition of OIH is also related to the exposure to opioids during surgery, depending of the dose, the time of exposition and the type of opioid. This condition can be modulated, specially in the perioperative context. It has been seen in healthy volunteers and in animal models, than the use of propranolol can modulate this phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the dose of propranolol required to modulate adequately OIH. The objective of this work is to evaluate the efficacy of propranolol in the modulation of opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2016
Shorter than P25 for phase_4
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
First Submitted
Initial submission to the registry
September 12, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedFirst Posted
Study publicly available on registry
October 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedOctober 27, 2016
October 1, 2016
6 months
September 12, 2016
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative opioid use
Dose of opioid required to manage pain adequately
24 hours posterior to surgery
Secondary Outcomes (4)
Pain thresholds (heat)
24 hours posterior to surgery
Pain thresholds (cold)
24 hours posterior to surgery
Pain thresholds (tactile sensitivity)
24 hours posterior to surgery
Temporal changes in pain sensibility
24 hours posterior to surgery
Study Arms (3)
Placebo
PLACEBO COMPARATORSaline solution by target controlled infusion
Propranolol at 5ng/ml target dose
ACTIVE COMPARATORPropranolol iv by target controlled infusion, to achieve a plasmatic concentration of 5ng/ml
Propranolol at 15ng/ml target dose
ACTIVE COMPARATORPropranolol iv by target controlled infusion, to achieve a plasmatic concentration of 15ng/ml
Interventions
propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective laparoscopic cholecystectomy
- American Society of Anesthesiology Score (ASA) I-II
You may not qualify if:
- Medical history of cardiac disease
- Medical history of respiratory disease
- Regular use of beta blockers
- Known allergies to drugs used in the study
- Known history of illicit drugs use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2016
First Posted
October 17, 2016
Study Start
October 1, 2016
Primary Completion
April 1, 2017
Study Completion
May 1, 2017
Last Updated
October 27, 2016
Record last verified: 2016-10