postoperative pain
Conditions
Interventions
Group 1: Patients with a primary, unilateral, or bilateral inguinal hernia intending to undergo robotic transabdominal preperitoneal (rTAPP) inguinal hernia repair.
Sponsors
Universität Basel, Departement Pharmazeutische Wissenschaften
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with a primary, unilateral, or bilateral inguinal hernia intending to undergo robotic transabdominal preperitoneal (rTAPP) inguinal hernia repair. - Patient signed the informed consent form. - Patient consented to undergo a pharmacogenetic analysis with Stratipharm®, Humatrix AG, and signed the Stratipharm® laboratory requisition.
Exclusion criteria
Exclusion criteria: - History of chronic pain syndrome. - Pain attributable to current malignant disease or chronic infection. - Lumbar Disc Syndrome with current pain. - Disease impairing central or peripheral nerve function. - Previous neurectomy. - Opioid addiction and/or enrollment in an opioid substitution program. - Recurrent inguinal hernia. - Patients with prior operations affecting sensitivity in the inguinal region (e.g., urological surgery). - Pregnancy. - Advanced dementia or other cognitive impairments hindering comprehension of the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective of this observational study is to examine the association between different CYP2D6 phenotypes and the perceived pain intensity six weeks after inguinal hernia surgery with the rTAPP approach. The primary endpoint is defined as the severity of pain six weeks postoperatively, determined by the European Hernia Society quality-of-life (EuraHS-QoL) postoperative score, considering the domain "Pain" (range 0–30, with an average range of 0-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary endpoints are defined: - Association between CYP2D6 phenotype and quality of life six weeks postoperatively: Determined by the EuraHS-QoL postoperative score, focusing on the domains of "Pain" and "Restriction of Activities" (range 0-70, with an average range of 0-10). - Association between CYP2D6 phenotype and preoperative pain severity: Determined by the EuraHS-QoL preoperative score, specifically examining the "Pain" domain (range 0–30, with an average range of 0-10). - Association between specific CYP2D6 genotypes and postoperative pain severity six weeks after inguinal hernia surgery: Determined by the EuraHS-QoL postoperative score, focusing on the "Pain" domain (range 0–30, with an average of 0-10). - Association between other genetic variants, including the COMT rs4680 genotype and OPMR1 rs1799971 genotype, and pain severity before and six weeks after inguinal hernia surgery: Determined by the EuraHS-QoL pre- and postoperative scores, considering the "Pain" domain (range 0–30, with an average of 0-10). - Association between other genetic variants, including the COMT rs4680 genotype and OPMR1 rs1799971 genotype, and quality of life before and six weeks after inguinal hernia surgery: Determined by the EuraHS-QoL pre- and postoperative scores, considering the domains of "Pain" and "Restriction of Activities" (range 0-70, with an average of 0-10). - Association between pain severity and combinations of genetic markers including CYP2D6 phenotype, COMT rs4680 genotype, and OPMR1 rs1799971 genotype. - Graphical representation of the development of pain over time for different groups defined by CYP2D6 phenotypes, COMT rs4680 genotype, and OPMR1 rs1799971 genotype in separate graphs. - Possible potential of pharmacogenetic (PGx) panel test in patients undergoing hernia surgery: The possible potential of the PGx panel test will be assessed based on the proportion of patient exhibiting abnormal phenotypes in drug metabolizing enzymes suc | — |
Countries
Switzerland
Contacts
Public ContactFlorine Wiss
Universität Basel, Departement Pharmazeutische Wissenschaften
Outcome results
None listed