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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Inguinal Hernia
• Intervention / Treatment: Drug: Bupivacaine; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine; injection, 25 mg, once, 5 min	Drug: Bupivacaine; 10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord; Other Names: Bupivacain "SAD"
Placebo Comparator: Placebo; injection, 10 ml 0.9% sodium chloride, once, 5 min	Drug: Placebo; 10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord; Other Names: Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thermal thresholds	Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo	20 min
Pressure pain thresholds	Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo	20 min
Sensory mapping	Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo	20 min
Suprathreshold heat stimulation	Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo	20 min
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
Sleep quality	Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo	7 days

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Mads U Werner, MD, Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK; Study Director: Henrik Kehlet, MD, Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: February 14, 2014
• First Submitted That Met QC Criteria: February 14, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Chronic Pain; Outcome; Surgical Procedure, Operative; Inguinal Hernia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: H-3-2011-130-open; 2612-1006 (Other Identifier: Danish Medicines Agency)