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Trigger-point Blockade in Persistent Pain After Laparoscopical Groin Hernia Repair (Trigger-lap)

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University of Copenhagen

Status and phase

Completed
Phase 3

Conditions

Chronic Pain

Treatments

Drug: Bupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT02065804
H-3-2011-130-lap

Details and patient eligibility

About

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 laparoscopical groin hernia repair.

Full description

This placebo-controlled, randomized, double-blind, cross-over study in subjects with severe pain after laparoscopically assisted groin hernia repair, 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with persistent pain (< 6 mo) after laparoscopical 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 writing or speech
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

14 participants in 2 patient groups, including a placebo group

Active drug
Experimental group
Description:
10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
Treatment:
Drug: Bupivacaine
Placebo
Placebo Comparator group
Description:
10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord
Treatment:
Drug: Bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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