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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02934763
Other study ID # 16-145
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received September 12, 2016
Last updated October 26, 2016
Start date October 2016
Est. completion date May 2017

Study information

Verified date October 2016
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority Chile: Comité de Ética Científico
Study type Interventional

Clinical Trial 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.


Description:

This is a randomized controlled study, comparing 2 interventions with a placebo. The interventions will be use of propranolol, at different doses, to achieve specific plasmatic concentrations.

80 patients will be required to find a difference of 20% in the primary outcome.

The primary outcome to be measured is the postoperative use of opioids in the post anesthesic care unit.

Secondary outcomes, will be the amount of opioids used in the following 24 hours to the surgery, the time to the first dose of analgesia in the post anesthesic care unit, and the change in the pain thresholds, evaluated as pain by pressure and by tactile sensitivity, before and after surgery.

Also, as a secondary outcome, in a group than will not receive the study drug, we will evaluate the temporal changes in opioid induced hyperalgesia, by pain sensitivity measured in the postoperative hours 2, 4 and 24. 10 patients receiving placebo will be part of this additional measures.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date May 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients scheduled for elective laparoscopic cholecystectomy

- American Society of Anesthesiology Score (ASA) I-II

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Propranolol
propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
Saline
Saline as placebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative opioid use Dose of opioid required to manage pain adequately 24 hours posterior to surgery No
Secondary Pain thresholds (heat) Evaluation of the threshold to perceive a heat perception as pain 24 hours posterior to surgery No
Secondary Pain thresholds (cold) Evaluation of the threshold to perceive a cold perception as pain 24 hours posterior to surgery No
Secondary Pain thresholds (tactile sensitivity) Evaluation of pain by tactile sensitivity, using the PinPrick system 24 hours posterior to surgery No
Secondary Temporal changes in pain sensibility Evaluation of pain by tactile sensitivity, using the PinPrick system 24 hours posterior to surgery No
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