Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair

Chronic Pain Clinical Trial

— Trigger-open  

Official title:

Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065219
• Other study ID #: H-3-2011-130-open
• Secondary ID: 2612-1006
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2014
• Last updated: November 23, 2016
• Start date: November 2013
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

Groin hernia repair is a common procedure performed in approximately 2,000 patients per one million inhabitants. Severe chronic pain following groin hernia repair is seen in 2-5% of the patients indicating that a large number of patients each year suffer from debilitating reduction in health-related quality of life.

This study examines the effect of ultra-sound guided blocks with local anesthesia in the groin in regard to pain relief and sleep quality.

The hypothesis of the study is that a block will confer significant pain relief to patients with severe chronic pain following open groin hernia repair.

Description:

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after open groin hernia, examines the effect of an ultra-sound guided local anesthetic block of a trigger-point, situated near the spermatic cord at the superficial inguinal ring. In order to compare effects and distribution of the blocks in patients vs. healthy subjects, the block is tested and examined in volunteers using a similar methodology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2015
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with persistent pain (< 6 mo) after open groin hernia repair

• Patients with maximal pain area 3 cm or less from the superficial inguinal ring

• Patients living in the Capital Region of Denmark (Region Hovedstaden) or the Region of Zealand (Region Sjælland)

Exclusion Criteria:

• Known allergy to bupivacaine or other local anesthetics of amide-type

• Declared incapable of making his/hers own affairs

• Does not comprehend Danish in the written or spoken language

• Cognitive impairment to a degree influencing the testing reliability

• Known recurrence of the inguinal hernia

• Other surgical procedures performed in the groin or on the external genitals

• Neuropathy affecting the groin region caused by other conditions, e.g. post-stroke, multiple sclerosis, herniated intervertebral disc

• Abuse of alcohol or drugs

• Unable to cooperate with the sensory examinations

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Bupivacaine
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
• Placebo
10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord

Locations

Country	Name	City	State
Denmark	Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normalized summed pain intensity difference (SPID)	The number of patients with normalized summed pain intensity differences (SPID) of more or equal to 50% after bupivacaine AND SPID less or equal to 25% after placebo.	20 min	No
Secondary	Thermal thresholds	Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo	20 min	Yes
Secondary	Suprathreshold heat stimulation	Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo	20 min	No
Secondary	Pressure pain thresholds	Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo	20 min	Yes
Secondary	Sensory mapping	Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo	20 min	No
Secondary	Pain questionnaire	Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo	7 days	No
Secondary	Sleep quality	Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo	7 days	No