The effect of wound instillation of a novel purified capsaicin formulation on postherniotomy pain: a double-blind, randomized, placebo-controlled study

BACKGROUND: Acute postoperative pain is common after most surgical procedures. Despite the availability of many analgesic options, postoperative pain management is often unsatisfactory. Purified capsaicin (ALGRX 4975 98% pure) has demonstrated prolong inhibition of C-fiber function in in vitro, preclinical, and clinical studies, and may be an effective adjunct to postoperative pain management. METHODS: We performed a single-center, randomized, double-blind, placebo-controlled study of the analgesic efficacy of a single intraoperative wound instillation of 1000 mu g ultrapurified capsaicin (ALGRX 4975) after open mesh groin hernia repair in 41 adult male patients. The primary end-point was average daily visual analog scale (VAS) pain scores during the first week after surgery assessed as area under the curve (AUC). Pain was recorded twice daily in a pain diary for 4 wk. Physical examination and laboratory tests were done before and I wk after surgery, together with recordings of adverse events up to 28 days. Adverse events were recorded. Data were also analyzed using a mixed-effects analysis with NONMEM. RESULTS: VAS AUC was significantly lower during the first 3 days postoperatively (P < 0.05), but not for the whole I or 4 wk postoperatively. Mixed-effects analysis with NONMEM revealed that pain scores were significantly lower (P < 0.05) in the capsaicin group during the first 4 days. No clinically significant serious adverse events were observed, although a mild transient increase in liver enzymes was seen more often in the capsaicin-treated group. CONCLUSION: In the setting of a well-defined analgesic protocol standard, VAS AUC analysis and a mixed-effect analysis showed superior analgesia of capsaicin relative to placebo during the first 3-4 days after inguinal hernia repair

Long-term Exposure to Ambient Air Pollution and Incidence of Brain Tumor: the European Study of Cohorts for Air Pollution Effects (ESCAPE)

acceptedVersio

Virkninger av støy fra jagerfly på befolkningen nær militære flyplasser

publishedVersio

Harmonizing neuropathic pain research: outcomes of the London consensus meeting on peripheral tissue studies

Neuropathic pain remains difficult to treat, with drug development hampered by an incomplete understanding of the pathogenesis of the condition, as well as a lack of biomarkers. The problem is compounded by the scarcity of relevant human peripheral tissues, including skin, nerves, and dorsal root ganglia. Efforts to obtain such samples are accelerating, increasing the need for standardisation across laboratories. In this white paper, we report on a consensus meeting attended by neuropathic pain experts, designed to accelerate protocol alignment and harmonization of studies involving relevant peripheral tissues. The meeting was held in London in March 2024 and attended by 28 networking partners, including industry and patient representatives. We achieved consensus on minimal recommended phenotyping, harmonised wet laboratory protocols, statistical design, reporting, and data sharing. Here, we also share a variety of relevant standard operating procedures as supplementary protocols. We envision that our recommendations will help unify human tissue research in the field and accelerate our understanding of how abnormal interactions between sensory neurons and their local peripheral environment contribute towards neuropathic pain

Inguinal hernia surgery in the Netherlands: are patients treated according to the guidelines?

Purpose In 2003, a dedicated Dutch committee developed vidence-based guidelines for the treatment of nguinal hernia (IH) in children and adults. The aim of this tudy was to describe trends in hernia care before and after he publication of the guidelines on IH surgery in the etherlands. ethods Originally, a retrospective baseline analysis of H surgery in 90 Dutch hospitals was performed among atients treated for IH in 2001. The results of this baseline nalysis were compared with a recently performed second nalysis of patients treated for IH in 2005. esults In children\\4 years of age, the study showed a ignificant decrease of contralateral explorations. In adults, he study showed that significantly more patients were reated with a mesh-based repair in 2005 (95.9 vs. 78.8%, <0.01eover, there was an increase of patients ith bilateral hernia treated with an endoscopic technique 41.5 vs. 22.3%, P<0.01) and more patients were treated n day surgery (53.5 vs. 38.6%, P<0.01). Lastly, a decline n operations performed for recurrent IH in adults was bserved (10.9 vs. 13.3%, P<0.01). onclusion This study showed that most patients with IH n the Netherlands were treated according to the main ecommendations of the Dutch evidence-based guidelines

Ten-year audit of Lichtenstein hernioplasty under local anaesthesia performed by surgical residents

<p>Abstract</p> <p>Background</p> <p>To analyse in a prospective trial the long-term results of Lichtenstein hernioplasty performed by surgical trainees.</p> <p>Methods</p> <p>Training of tension-free Lichtenstein hernia operation was started in our ambulatory unit as an outpatient procedure under local anaesthesia in 1996. After performing 36 teaching operations together with residents and their supervising specialist, 281 patients were operated during 1996-2000 either by one senior consultant (n = 141) or by 12 surgical trainees (n = 140). After 10 years, 247 (88%) patients were available for the long-term assessment.</p> <p>Results</p> <p>After one month postoperatively, the rate of wound infections (consultant 1.1%, residents 0.7%) and hematomas (consultant 1.1%, residents 3.0%) were low and not related to surgeon's training level (ns). Only 6 (2.1%) clinically evident recurrences were found after 10 years: two after specialist repair and four after trainee repair (ns). Although one third of the patients reported some discomfort after 3 and 10 years, 93-95% of the patients were very satisfied with the operation, with no statistical difference between the surgeons.</p> <p>Conclusion</p> <p>Ambulatory open mesh repair under local anaesthesia was a safe operation and the long-term results were acceptable among the patients operated by surgical trainees.</p

Investigating the effect of intra-operative infiltration with local anaesthesia on the development of chronic postoperative pain after inguinal hernia repair. A randomized placebo controlled triple blinded and group sequential study design [NCT00484731]

<p>Abstract</p> <p>Background</p> <p>Inguinal hernia repair is one of the most frequently performed procedures in Switzerland (15'000/year). The most common complication postoperatively is development of chronic pain in up to 30% of all patients irrespective of the operative technique.</p> <p>Methods/Design</p> <p>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 20 ml 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).</p> <p>The study started on July 2006. 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.</p> <p>Discussion</p> <p>Using a group sequential study design the minimum number of patients are enrolled to reach a valid conclusion before the end of the study.</p> <p>To limit subjectivity, both a VAS and the Pain Matcher^®device are used for the evaluation of pain. This allows us also to compare these two methods and further assess the use of Pain Matcher^®in clinical routine.</p> <p>The occurrence of chronic pain after inguinal hernia repair has been in focus of several clinical studies but the reduction of it has been rarely investigated. We hope to significantly reduce the occurrence of this complication with our investigated intervention.</p> <p>Trial Registration</p> <p>Our trial has been registered at ClinicalTrials.gov. The trial registration number is: [NCT00484731].</p