An interventional study of Infiltration with Saline and Infiltration with Bupivacaine in Chronic Pain, sponsored by Luzerner Kantonsspital. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Luzerner Kantonsspital · Not applicable, Interventional, and Prevention
The effect of intraoperative infiltration of the operation site with bupivacain on the development of chronic pain is the object of our trial. We hypothesize that the occurrence of chronic pain in the goup of patients receiving the infiltration will be 50% less than in the placebo group receiving normal saline. The study is a randomized controlled triple blinded trial with a sequential study design.
264 patients scheduled for an inguinal hernia repair using one of three procedures (Lichtenstein, Barwell and TEP = total extraperitoneal hernioplasty) are being randomly allocated intra-operatively into two groups. Group I patients receive a local injection of 20ml Carbostesin® 0.25% at the end of the operation according to a standardised procedure. Group II patients get a 20 ml placebo (0.9% Saline) injection. We use pre-filled identically looking syringes for blinded injection, i.e. the patient, the surgeon and the examinator who performs the postoperative clinical follow-ups remain unaware of group allocation. The primary outcome of the study is the occurrence of developing chronic pain (defined as persistent pain at 3 months FU) measured by VAS and Pain Matcher® device (Cefar Medical AB, Lund, Sweden).
In addition to a sample size re-evaluation three interim analyses are planned after 120, 180 and 240 patients had finished their 3-months follow-up to allow for early study termination.
2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.
This study's enrollment of 404 is above the median of 60 across 2,161 interventional studies indexed under Chronic Pain.
Browse Chronic Pain studies →Luzerner Kantonsspital is the lead sponsor of 60 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Injection with Saline instead of Bupivacain
Procedure: Infiltration with Saline
Injection with Bupivacaine
Procedure: Infiltration with Bupivacaine
Infiltration with Bupivacaine according to protocol
occurrence of chronic pain
Time frame: 3 months
Level of Pain:Pain Matcher®,VAS;Areas of hyperalgesia,hypaesthesia Hospitalization:Length of stay (days) ASA-Classification Beginning of mobilisation (days) Return to work or normal activity (days and %) Quality of life (SF36)
Time frame: one year
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Luzerner Kantonsspital