Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol

Hyperalgesia Clinical Trial

Official title:

Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol, in Laparoscopic Abdominal Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02934763
• Other study ID #: 16-145
• 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

• Hyperalgesia

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