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

Chronic Pain Clinical Trial

— Trigger-lap  

Official title:

Trigger-point Blockade in Persistent Pain After Laparoscopically Assisted Groin Hernia Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065804
• Other study ID #: H-3-2011-130-lap
• Status: Completed
• Phase: Phase 3
• First received: February 15, 2014
• Last updated: October 16, 2017
• Start date: October 2013
• Est. completion date: July 2014

Study information

• Verified date: October 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Bupivacaine
injection, once, 5 min

Locations

Country	Name	City	State
Denmark	Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Thermal thresholds	Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo	20 min
Secondary	Suprathreshold heat stimulation	Quantitative changes in pain rating to suprathreshold heat stimulation after bupivacaine compared to placebo	20 min
Secondary	Pressure pain thresholds	Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo	20 min
Secondary	Sensory mapping	Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo	20 min
Secondary	Pain questionnaire	Quantitative changes in summed pain intensity differences (SPIDs) assessed morning and evening after bupivacaine compared to placebo	7 days
Secondary	Sleep quality questionnaire	Quantitative changes in sleep quality assessed each morning after bupivacaine compared to placebo	7 days

External Links

•   Patient Information for Laparoscopic Inguinal Hernia Repair from SAGES (Society of American Gastrointestinal and Endoscopic Surgeons)