Trigger-point Blockade in Persistent Pain After Open Groin Hernia Repair
- Registration Number
- NCT02065219
- Lead Sponsor
- University of Copenhagen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo injection, 10 ml 0.9% sodium chloride, once, 5 min Bupivacaine Bupivacaine injection, 25 mg, once, 5 min
- Primary Outcome Measures
Name Time Method Normalized summed pain intensity difference (SPID) 20 min 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.
- Secondary Outcome Measures
Name Time Method Suprathreshold heat stimulation 20 min Quantitative changes in pain ratings to suprathreshold heat stimulation after bupivacaine compared to placebo
Pressure pain thresholds 20 min Quantitative changes in pain rating to pressure algometry stimulation after bupivacaine compared to placebo
Pain questionnaire 7 days Quantitative changes in summed pain intensity differences (SPIDs) during rest, movement and during auto-palpation, assessed morning and evening after bupivacaine compared to placebo
Sleep quality 7 days Quantitative changes in sleep quality assessed each morning, after bupivacaine compared to placebo
Thermal thresholds 20 min Quantitative changes in thermal thresholds (warmth detection threshold, cool detection thresholds, heat pain threshold) after bupivacaine compared to placebo
Sensory mapping 20 min Quantitative changes in area of cool hypoesthesia assessed by a thermal roller after bupivacaine compared to placebo
Trial Locations
- Locations (1)
Multidisciplinary Pain Center, Neuroscience Center, Copenhagen University Hospital, DENMARK
🇩🇰Copenhagen, Denmark