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

Primary Purpose

Inguinal Hernia, Chronic Pain

Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine
Placebo
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Chronic Pain, Inguinal Hernia, Outcome, Surgical Procedure, Operative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivacaine

Placebo

Arm Description

injection, 25 mg, once, 5 min

injection, 10 ml 0.9% sodium chloride, once, 5 min

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 14, 2014
Last Updated
November 23, 2016
Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02065219
Brief Title
Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
Acronym
Trigger-open
Official Title
Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Chronic Pain
Keywords
Chronic Pain, Inguinal Hernia, Outcome, Surgical Procedure, Operative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine
Arm Type
Experimental
Arm Description
injection, 25 mg, once, 5 min
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
injection, 10 ml 0.9% sodium chloride, once, 5 min
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bupivacain "SAD"
Intervention Description
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord
Primary Outcome Measure Information:
Title
Normalized summed pain intensity difference (SPID)
Description
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.
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Thermal thresholds
Description
Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo
Time Frame
20 min
Title
Suprathreshold heat stimulation
Description
Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo
Time Frame
20 min
Title
Pressure pain thresholds
Description
Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo
Time Frame
20 min
Title
Sensory mapping
Description
Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo
Time Frame
20 min
Title
Pain questionnaire
Description
Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo
Time Frame
7 days
Title
Sleep quality
Description
Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mads U Werner, MD
Organizational Affiliation
Multidisciplinary Pain Center, Neuroscience Center, Rigshospitalet, Copenhagen University Hospital, DENMARK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Kehlet, MD
Organizational Affiliation
Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK
Official's Role
Study Director
Facility Information:
Facility Name
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
27199314
Citation
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.
Results Reference
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Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair

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