The Significance of Peripheral Input

NCT04764045 | Unknown

• 1 other identifier: NP-FM-19
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain

Keywords

Peripheral input; Trigger point injection; Post operative pain

Outcome Measures

Primary Outcomes (1)

• Change in worst pain in rest and in activity

  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

  30 minutes

Secondary Outcomes (2)

• 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 Arms (2)

Ropivacaine injection in trigger points

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Placebo injection in trigger points

PLACEBO COMPARATOR

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

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Injection of 1 ml Ropivacaine in all trigger points in and around scar. Injection of 1 ml saline in all trigger points in and around scar.

Also known as: Saline

Placebo injection in trigger points; Ropivacaine injection in trigger points

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400 NV, Denmark

RECRUITING

Related Publications (3)

• Wijayasinghe N, Ringsted TK, Bischoff JM, Kehlet H, Werner MU. The role of peripheral afferents in persistent inguinal postherniorrhaphy pain: a randomized, double-blind, placebo-controlled, crossover trial of ultrasound-guided tender point blockade. Br J Anaesth. 2016 Jun;116(6):829-37. doi: 10.1093/bja/aew071.

  PMID: 27199314 BACKGROUND

• Haroutounian S, Nikolajsen L, Bendtsen TF, Finnerup NB, Kristensen AD, Hasselstrom JB, Jensen TS. Primary afferent input critical for maintaining spontaneous pain in peripheral neuropathy. Pain. 2014 Jul;155(7):1272-1279. doi: 10.1016/j.pain.2014.03.022. Epub 2014 Apr 2.

  PMID: 24704366 BACKGROUND

• Haroutounian S, Ford AL, Frey K, Nikolajsen L, Finnerup NB, Neiner A, Kharasch ED, Karlsson P, Bottros MM. How central is central poststroke pain? The role of afferent input in poststroke neuropathic pain: a prospective, open-label pilot study. Pain. 2018 Jul;159(7):1317-1324. doi: 10.1097/j.pain.0000000000001213.

  PMID: 29570507 BACKGROUND

MeSH Terms

Conditions

Neuralgia; Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, clinical professor

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: February 21, 2021
• Study Start: November 20, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)