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

NCT ID: NCT02065219

Last Updated: 2016-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-05-31

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.

Conditions

Inguinal Hernia; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bupivacaine

injection, 25 mg, once, 5 min

Group Type: EXPERIMENTAL

Bupivacaine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Bupivacaine

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Bupivacain "SAD"; Normal saline

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

University of Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

mads u werner

MD, MDSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mads U Werner, MD

Role: PRINCIPAL_INVESTIGATOR

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

Henrik Kehlet, MD

Role: STUDY_DIRECTOR

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

Locations

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

Copenhagen, , Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 27199314 (View on PubMed)

Other Identifiers

2612-1006

Identifier Type: OTHER

Identifier Source: secondary_id

H-3-2011-130-open

Identifier Type: -

Identifier Source: org_study_id