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

NCT02065804 | Completed Phase 3

• 1 other identifier: H-3-2011-130-lap
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 laparoscopical groin hernia repair.

Conditions

Chronic Pain

Keywords

Herniorrhaphy; Surgical Equipment; Chronic Pain; Inguinal Herniorrhaphy; Laparoscopy; Surgical Outcome

Outcome Measures

Primary Outcomes (1)

• Normalized summed pain intensity differences (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

Study Arms (2)

Active drug

EXPERIMENTAL

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

Drug: Bupivacaine

Placebo

PLACEBO COMPARATOR

10 ml of normal saline deposited by ultra-sound guidance around the spermatic cord

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

injection, once, 5 min

Also known as: Bupivacain "SAD", 0.9% Sodium-chloride

Active drug; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

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 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

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

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Linderoth G, Kehlet H, Aasvang EK, Werner MU. Neurophysiological characterization of persistent pain after laparoscopic inguinal hernia repair. Hernia. 2011 Oct;15(5):521-9. doi: 10.1007/s10029-011-0815-z. Epub 2011 Apr 9.

  PMID: 21479588 BACKGROUND

MeSH Terms

Conditions

Chronic Pain

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mads Werner

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

  PRINCIPAL INVESTIGATOR

• Henrik Kehlet, MD, DMSc

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

  STUDY CHAIR

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, DMSc

Study Record Dates

• First Submitted: February 15, 2014
• First Posted: February 19, 2014
• Study Start: October 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)