Groin hernia repair MedDRA version: 18.0 Level: LLT Classification code 10049475 Term: Chronic pain System Organ Class: 100000004867
Conditions
Interventions
Trade Name: Naloxon "B. Braun"
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: NALOXONE
CAS Number: 465-65-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration t
Sponsors
Rigshospitalet, Copenhagen University Hospitals
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: • Healthy male • Age above 18 yrs and below 65 yrs • Signed informed consent • Participants submitted to unilateral, primary inguinal, open groin hernia repair 6-8 weeks prior to study start. • Surgical procedure a.m. Lichtenstein. • Urin-sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphone, dextromethorphan) • ASA I-II • Body mass index (BMI): 18 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Participants, who do not speak or understand Danish • Participants, who cannot cooperate with the investigation • Participants, who have had previous surgery in the groin region • Participants with pain at rest > 3 (NRS) • Activity-related pain in the surgical field > 5 (NRS) • Allergic reaction against morphine or other opioids (including naloxone), • Abuse of alcohol or drugs – according to investigator’s evaluation • Use of psychotropic drugs (exception of SSRI) • Neurologic or psychiatric disease • Chronic pain condition • Regular use of analgesic drugs • Skin lesions or tattoos in the assessment areas • Nerve lesions in the assessment sites (e.g., after trauma, disc herniation, etc.) • Use of prescription drugs one week before the trial • Use of over-the-counter drugs 48 hours before the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal aim of the study is to investigate whether the administration of naloxone, a selective mu-opioid receptor (MOR) antagonist, can re-introduce pain (at rest, during movement and in pressure-evoked condition) and hyperalgesia six to eight weeks after unilateral, primary, open groin hernia repair with mesh-implantation (GHR). A three-step the target-controlled-infusion (TCI) model is employed. ;Secondary Objective: not applicable;Primary end point(s): (Abbreviations: BL = baseline; NRS = numerical rating scale (pain; 0 to 10); NX = naloxone; PL = placebo; TCI = during target-controlled-infusion): 1. The primary endpoint is based on a summated measure (SM) of resting pain (RP), movement-related pain (MP) and pressure evoked pain (PM). NRS(SM) = NRS(RP) + NRS(MP) + NRS(PM) 2. the summed pain intensities (SPIs) are calculated as: (BL-SPI[NX]) and (TCI-SPI[NX]), and, (BL-SPI[PL]) and (TCI-SPI[PL]), where (TCI-SPI) indicate SM-value at highest obtainable TCI-step (Fig. 2) 3. The summed pain intensity differences (SPIDs) are the differences: SPID[NX] = (TCI-SPI[NX]) – (BL-SPI[NX]) and SPID[PL] = (TCI-SPI[PL]) - (BL-SPI[PL]) 4. The primary endpoint is SPIDs ;Timepoint(s) of evaluation of this end point: Baseline (pre-infusion; 0 min); Step 1 (TCI-infusion 1 [naloxone: 0.25 mg/kg]: 15 to 25 min); Step 2 (TCI-infusion 2 [naloxone: 0.75 mg/kg]: 39 to 49 min); Step 3 (TCI-infusion 3 [naloxone: 2.25 mg/kg]: 65 to 75 min). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pressure pain thresholds (PPT) by algometry at the surgical site compared to the contralateral site, secondary hyperalgesia/allodynia areas at surgical site and contralateral site, psychometrics (Hospital Anxiety and Depression Scale [HADS], Pain Catastrophizing Scale [PCS]) and ratings by Clinical Opiate Withdrawal Scale (COWS). ;Timepoint(s) of evaluation of this end point: Pressure pain thresholds (PPT) and secondary hyperalgesia/allodynia areas are assessed Baseline (pre-infusion; 0 min); Step 1 (TCI-infusion 1: 15 to 25 min); Step 2 (TCI-infusion 2: 39 to 49 min); Step 3 (TCI-infusion 3: 65 to 75 min). Clinical Opiate Withdrawal Scale (COWS) assessments are made at Baseline (pre-infusion; 0 min); Step 1 (TCI-infusion 1: 13 to 15 min); Step 2 (TCI-infusion 2: 37 to 39 min); Step 3 (TCI-infusion 3: 63 to 65 min). Psychometrics (Hospital Anxiety and Depression Scale [HADS], Pain Catastrophizing Scale [PCS]) and ratings by Clinical Opiate Withdrawal Scale (COWS) are only assessed at Baseline (pre-infusion; 0 min). | — |
Countries
Denmark
Contacts
Public ContactThomas K. Ringsted
Rigshospitalet, Copenhagen University Hospitals
Outcome results
None listed