NCT02065219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

February 14, 2014

Last Update Submit

November 23, 2016

Conditions

Inguinal HerniaChronic Pain

Keywords

Chronic PainInguinal HerniaOutcomeSurgical Procedure, Operative

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Thermal thresholds

    20 min

  • Suprathreshold heat stimulation

    20 min

  • Pressure pain thresholds

    20 min

  • Sensory mapping

    20 min

  • Pain questionnaire

    7 days

  • +1 more secondary outcomes

Study Arms (2)

Bupivacaine

EXPERIMENTAL

injection, 25 mg, once, 5 min

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

BupivacaineDRUG

10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord

Also known as: Bupivacain "SAD"
Bupivacaine
PlaceboDRUG

10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related 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 Anaesth. 2016 Jun;116(6):829-37. doi: 10.1093/bja/aew071.

    PMID: 27199314RESULT

MeSH Terms

Conditions

Hernia, InguinalChronic Pain

Interventions

BupivacaineSaline Solution

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Mads U Werner, MD

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

    PRINCIPAL INVESTIGATOR

  • Henrik Kehlet, MD

    Section of Surgical Pathophysiology, Juliane Marie Center, Copenhagen University Hospital, DENMARK

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MDSc

Study Record Dates

First Submitted

February 14, 2014

First Posted

February 17, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2014

Study Completion

May 1, 2015

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

DK(1)