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Clinical Trials/NCT04764045
NCT04764045
Unknown
Not Applicable

The Significance of Peripheral Input in Patients With Post Surgery Neuropathic Pain: Evaluation of Trigger Point Anesthesia. A Double-blind, Randomized, Controlled Exploratory Study

Bispebjerg Hospital1 site in 1 country12 target enrollmentNovember 20, 2019
InterventionsRopivacaine

Overview

Phase
Not Applicable
Intervention
Ropivacaine
Conditions
Neuropathic Pain
Sponsor
Bispebjerg Hospital
Enrollment
12
Locations
1
Primary Endpoint
Change in worst pain in rest and in activity
Last Updated
5 years ago

Overview

Brief Summary

The investigators want to examine trigger point injections of local anesthetics, in patients with post operative neuropathic pain, determine changes in sensory disturbances such as allodynia, hyperalgesia and thermal sensitivity and examine whether trigger point injections will attenuate pain in rest and activity.

Detailed Description

The presence of cutaneous trigger points in the surgical incision of patients with post-surgery pain has been shown in our pain clinic, all patients have persistent pain for more than 3 month and different sensory disturbances. Examinations with trigger point injections of local anesthetics have been used to determine the influence of peripheral changes and the significance of afferent input on persistent post-surgery neuropathic pain. In the present study the investigators will document the influence of cutaneous trigger point injections for both subjective pain experience and objective findings in the area such as allodynia, hyperalgesia and thermal sensitivity. The investigators expect reduction in spontaneous pain intensity and de-crease in peripheral sensory disturbances and will determine the significance of peripheral input in persistent neuropathic pain. The investigators aim to investigate whether injection of local anesthesia into trigger points compared with placebo (saline) injection will attenuate pain and normalize abnormal sensations, such as hyperalgesia and allodynia. The investigators believe this to be an important investigation to understand the mechanisms behind chronic post-surgery pain.

Registry
clinicaltrials.gov
Start Date
November 20, 2019
End Date
May 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Finn Borgbjerg Moltke

MD, clinical professor

Bispebjerg Hospital

Eligibility Criteria

Inclusion Criteria

  • Age \> 18 years old
  • Patients with chronic pain (daily VAS pain scores \>30 mm) for at least 3 months after knee, shoulder or foot surgery
  • Patients with at least one identifiable trigger point in relation to incision from the knee, shoulder or foot surgery. A trigger point is defined as an ar-ea in relation to the incision from surgery, in which a light pressure from a cotton pin radiate pain to the nearby area, and exudes a motor reflex causing withdrawal of the leg
  • A written informed consent to participate in the study after having fully understood the contents of the protocol and restrictions

Exclusion Criteria

  • Patients who cannot cooperate
  • Patients who cannot understand or speak Danish.
  • Patients with allergy to the drugs used in the study
  • Patients in treatment with vitamin K antagonists.
  • Patients with other pain conditions
  • Patients with diabetes

Arms & Interventions

Ropivacaine injection in trigger points

Ropivacaine injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes

Intervention: Ropivacaine

Placebo injection in trigger points

Saline injection 1 ml in all trigger points in and around scar after operation in knee, shoulder and foot, one time, duration 3 minutes

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Change in worst pain in rest and in activity

Time Frame: 30 minutes

Change in worst pain assessed on a visual analogue scale (VAS, 0-100 mm) at rest and after stair walking/abduction of shoulder, before and after trigger point injections compared to baseline pain score

Secondary Outcomes

  • Change in area of sensory disturbances(30 minutes)
  • Change in warm and cold detection, threshold and tolerance before and after intervention in area with hyperalgesia compared to normal skin(30 minutes)

Study Sites (1)

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