Topical nifedipine for post-haemorrhoidectomy pain relief: randomized, prospective, double-blind trial protocol.
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SUBMITTER: Steen CJ
PROVIDER: S-EPMC10516616 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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Topical nifedipine for post-haemorrhoidectomy pain relief: randomized, prospective, double-blind trial protocol.
Steen Christopher J CJ Yap Raymond J RJ Asghari-Jafarabadi Mohammad M Sutton Adam A Chin Martin M Carne Peter P Bell Stephen W SW McMurrick Paul J PJ
BJS open 20230901 5
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Project description:IntroductionOsteoarthritis (OA) pain is a major cause of long-term disability and chronic pain in the adult population. One in five patients does not receive satisfactory pain relief, which reflects the complexity of chronic pain and the current lack of understanding of mechanisms of chronic pain. Recently, duloxetine has demonstrated clinically relevant pain relief, but only in half of treated patients with OA. Here, the aim is to investigate the neural mechanisms of pain relief and neural signatures that may predict treatment response to duloxetine in chronic knee OA pain.Methods and analysisThis is an ongoing single-centre randomised placebo-controlled mechanistic study (2:1 (placebo) allocation), using a multimodal neuroimaging approach, together with psychophysiological (quantitative sensory testing), genetics and questionnaire assessments. Eighty-one subjects with chronic knee OA pain are planned to power for between-group comparisons (placebo, duloxetine responder and duloxetine non-responder). Participants have a baseline assessment and, following 6 weeks of duloxetine (30 mg for 2 weeks, then 60 mg for 4 weeks), a follow-up evaluation. Brain imaging is performed at 3T with blood-oxygen-level dependent functional MRI at rest and during pin-prick nociceptive stimulation for main outcome assessment; arterial spin labelling and structural imaging (T1-weighted) for secondary outcome assessment. Questionnaires evaluate pain, negative affect, quality of sleep and cognition.Ethics and disseminationThe study has been approved by the East Midlands, Nottingham and is being carried out under the principles of the Declaration of Helsinki (64th, 2013) and Good Clinical Practice standards. Results will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberThis trial is registered at ClinicalTrials.gov (NCT02208778).This work was supported by Arthritis Research UK (Grant 18769).
| S-EPMC5541453 | biostudies-literature
Project description:BackgroundFirst-line pharmacotherapy for neuropathic pain entails the use of systemic antidepressants and anticonvulsants. These drugs are not optimally effective and poorly tolerated, especially for older patients with comorbid conditions. Given the high number of such patients, there is a need for a greater repertoire of safer and more effective analgesics. Clonidine and pentoxifylline are vasodilator agents that work synergistically to enhance tissue perfusion and oxygenation. The topical administration of these drugs, individually and in combination, has shown anti-nociceptive properties in rodent models of neuropathic pain. A topically-administered combination of clonidine and pentoxifylline also effectively reduced the intensity of both spontaneous and evoked pain in healthy volunteers with experimentally-induced neuropathic pain. The next step in advancing this formulation to clinical use is the undertaking of a phase II clinical study to assess its efficacy and safety in neuropathic pain patients.Methods/designThis is a study protocol for a randomized, double-blind, placebo-controlled, phase II clinical trial with a cross-over design. It is a single-centered, 5-week study that will enroll a total of 32 patients with post-traumatic peripheral neuropathic pain. Patients will be treated topically with either a combination of clonidine and pentoxifylline or placebo for a period of 2 weeks each, in randomly assigned order across patients, with an intervening washout period of 1 week. The primary outcome measures of the study are the intensity of spontaneous pain recorded daily in a pain diary with a visual analog scale, and the degree of mechanical allodynia evoked by a brush stimulus. The secondary outcome measures of the study include scores of pain relief and change in the area of punctate hyperalgesia. This trial has been prospectively registered with ClinicalTrials.gov on November 1, 2017. ClinicalTrials.gov Identifier: NCT03342950 .DiscussionThe analgesic use of topical treatment with clonidine and pentoxifylline in combination has not been investigated in post-traumatic neuropathic pain. This study could generate the first evidence for the efficacy and safety of the formulation in alleviating pain in patients with neuropathic pain. Furthermore, this trial will provide objective grounds for the investigation of other agents that enhance tissue oxygenation in the topical treatment of peripheral neuropathic pain.Trial registrationThis trial has been registered with ClinicalTrials.gov owned by NIH's US National Library of Medicine. ClinicalTrials.gov NCT03342950 . Registered on November 1, 2017 (trial was prospectively registered).Protocol version and identifiersThis is protocol version 5, dated June 2018. McGill University Health Center (MUHC) Reaseach Ethics Board (REB) identification number: TTNP 2018-3906.
| S-EPMC7890866 | biostudies-literature
Project description:ObjectiveTo evaluate the effects of cryotherapy on pain scores and satisfaction levels of patients during cataract surgery under topical anesthesia. Eighty patients aged between 55 and 75 years scheduled for cataract surgery were randomly allocated to two study groups to receive topical anesthesia with cryotherapy (TC) or topical anesthesia alone (T) groups. Visual analog pain scores, patient satisfaction level, hemodynamic parameters, and quality of operating conditions were recorded.ResultsCryotherapy significantly reduced VAS pain scores during surgery (P = 0.014). Although no significant difference in postoperative pain scores, opioid consumption, heart rate, and mean arterial blood pressure was seen in the postoperative period. The surgeon reported better quality of operating conditions in the TC group (P = 0.018). Cryotherapy as a complementary method with topical anesthesia reduced pain scores of patients during surgery. It also produced a better quality of operating conditions for surgeons. There was no significant difference in either postoperative pain scores or opioid consumption. Trial registration This trial was registered at Iranian clinical trial registering: IRCT registration number: IRCT2017052734091N2.
| S-EPMC9241292 | biostudies-literature
Project description:BackgroundHaemorrhoidectomy is often complicated by significant post-operative pain, to which spasm of the internal anal sphincter is thought to be a contributing factor. This study appraises the evidence behind interventions aimed at lowering sphincter spasm to relieve post-haemorrhoidectomy pain.MethodsA Preferred Reporting Items for Systematic Reviews and Meta-analyses compliant systematic review was conducted. Medline, EMBASE, and CENTRAL databases were systematically searched. All RCTs which compared interventions targeting the internal anal sphincter to relieve pain post excisional haemorrhoidectomy were included. The primary outcome measure was pain on the visual analogue scale.ResultsOf the initial 10,221 search results, 39 articles were included in a qualitative synthesis, and 33 studies were included in a meta-analysis. Topical glyceryl trinitrate (GTN) reduced pain on day 7 (7 studies, 485 participants), with a mean difference and 95% confidence interval (MD, 95% CI) of -1.34 (-2.31; -0.37), I2 = 91%. Diltiazem reduced pain on day 3 on the VAS, and the MD was -2.75 (-398; -1.51) shown in five studies (n = 227). Botulinum toxin reduced pain on day 7, in four studies with 178 participants, MD -1.43 (-2.50; -0.35) I2 = 62%. The addition of Lateral Internal Sphincterotomy to haemorrhoidectomy reduced pain on day 2 in three studies with 275 participants, MD of -2.13 (-3.49; -0.77) I2 = 92%. The results were limited by high heterogeneity and risk of bias.ConclusionEvidence suggests that lateral sphincterotomy, administration of botulinum toxin and the application of topical diltiazem or GTN can reduce post-operative pain after haemorrhoidectomy. Lateral sphincterotomy should not be routinely used due to the risk of incontinence.
| S-EPMC9803754 | biostudies-literature
Project description:ObjectivesThe aim of the study was to prospectively evaluate the association between immediate pain relief from injections of local anesthetic with corticosteroid and subsequent pain relief up to 3 mos. The secondary aim was to examine the time until subjective pain relief after these injections.DesignThis was a single-center, prospective study of patients undergoing ultrasound-guided corticosteroid injections for musculoskeletal pain. Subjects completed follow-up surveys at 2 wks, 1 mo, and 3 mos postinjections. χ 2 tests and sensitivity analysis were used to examine the primary outcome, at least 50% relief from the injection. Regression modeling examined the effects of demographic and injection-related variables on outcome measures.ResultsA total of 132 patients were enrolled (55% female, mean age 52 yrs). Response rates were 87.1% at 2 wks and 77.2% at 3 mos. The positive likelihood ratios from 50% initial pain relief ranged from 1.22 to 1.29 at the three time points, whereas the negative likelihood ratios ranged from 0.54 to 0.63. More than 75% of participants reported subjective pain relief by day 4 after injection.ConclusionsThe predictive value of immediate pain relief for subsequent longer-term pain relief from corticosteroid-anesthetic injections is not particularly high. Most patients will obtain pain relief within 4 days of a corticosteroid injection.
| S-EPMC10448910 | biostudies-literature
Project description:IntroductionGenitourinary Syndrome of Menopause (GSM) defines a set of symptoms associated with an estrogen deficit involving alterations in organs genitourinary and that results in several urinary, genital, and sexual alterations. Brazilian women live about a third of their life after menopause, where hormonal changes occur along with clinical manifestations, characterized by vaginal and vulvar dryness, burning sensation, discomfort, vulvovaginal irritation, lack of lubrication, dyspareunia and urinary incontinence. Fractionated photothermolysis and radiofrequency systems, alone or in combination were tested to improve GSM.ObjectiveThe goal of this study is to elaborate a protocol to evaluate the clinical response of patients with symptoms of GSM after the application of photobiomodulation in the vulvar region.MethodIn this randomized, double-blind, placebo-controlled study protocol, women over 50 years of age who are in the postmenopausal period (amenorrhea for at least 12 months, with no pathology involved) with one or more symptoms of GSM will be randomly divided into two groups. The treatment group (n = 30) will receive four consecutive applications, weekly, using DMC laser diode (λ = 808 nm), 4J per point, 100mW of power, 1,016W/cm2, 8 sites in the vulvar region, The Placebo Group (n = 30) will be handled as treated, but with the laser turned off. The quality of life will be assessed using female sexual functioning index (FSFI-6), urinary incontinence questionnaire (ICIQ-SF), Quality of life will be analyzed using the female sexual functioning index (FSFI-6). The intensity of menopausal symptoms will be evaluated using a visual analogue scale (VAS), the vulvo vaginal atrophy will be measured by the Vaginal Health Index (VHI). Also, the vaginal temperature will be measured using a thermal camera, the pressure of the pelvic floor force (vaginal dynamometer) and a 1-hour Pad Test will be performed to quantify the urinary loss. With this procedure, we intend to obtain an overall better life quality and diminished symptoms in women with GSM. All assessments will be performed prior to the first irradiation and after the last one.Trial registrationThis protocol is registered at ClinicalTrials.gov under the number NCT05557799.
| S-EPMC11611114 | biostudies-literature
Project description:BackgroundSubjects with diabetes mellitus (DM) develop gait dysfunction contributing to falls, reluctance to perform activities and injuries. Neuropathic pain (NeP) related to diabetic peripheral neuropathy (DPN) is associated with increased gait variability that may contribute to gait dysfunction. We used a portable device (GaitMeter™) and related gait and balance measures to measure gait parameters in painful DPN (PDPN) subjects prior to and during analgesia. Our hypothesis was that PDPN subjects would have decreased gait step variability when receiving pharmacological relief of NeP.MethodsDPN subjects with at least moderate NeP were assessed in a randomized, double-blind crossover study of pregabalin versus placebo. The outcome measure was variability in step length and step velocity. Testing for Timed Get-Up-and-Go Test, Tinetti Mobility Scales, Sway Testing, a Physiological Profile Approach, and fall-related surveys were also performed. DPN severity was quantified using the Utah Early Neuropathy Score.ResultsPDPN subjects developed increased, rather than decreased, step length and step velocity variability during pregabalin treatment. There were no significant differences between cohorts for other physiological gait and balance testing. Non-significant NeP relief occurred in the pregabalin phase of study as compared with placebo. There was a negative relationship for step length with pain severity.ConclusionAnalgesia did not decrease gait variability in PDPN patients, and in fact, increased gait variability was seen during pregabalin treatment. Other important relationships of gait dysfunction with PDPN should be sought.
| S-EPMC4150964 | biostudies-literature
Project description:BackgroundHemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption.MethodsPatients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate.DiscussionMultimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics.Trial registrationClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.
| S-EPMC9235219 | biostudies-literature
Project description:Frostbite is a cold-related injury with a growing incidence among healthy subjects. Sequelae after frostbite are frequent and vary among individuals. Here, we studied the thermal response in the digits of hands and feet of five subjects who had recovered from previous frostbite, except for their lasting sequelae. We considered three different conditions: digits unaffected by frostbite nor sequelae (healthy), those affected but which did not suffer amputation (frostbitten without amputation), and the remainder/stumps of digits that underwent partial amputation (frostbitten with amputation). Three consecutive immersions in cold water (8°C; 3 min) interspersed by 1 minute of thermal recovery were performed. After 30 min, a topical 10% nifedipine preparation was applied to hands and feet, and the same cold exposure protocol to evaluate its effect was followed. In basal condition and immediately after each immersion, the temperature of individual digits was assessed using thermography. We observed different thermal responses among the different digits of hands and feet, even without the nifedipine treatment. Nifedipine had a cooling effect on healthy and post-amputated tissue without thermal stress. In cold conditions, topic nifedipine application improved the cold response in healthy fingers but had a negative effect on those from which parts had been amputated. The topical nifedipine had detrimental effects on toes in all conditions. Topical nifedipine can help to the preservation of healthy fingers exposed to cold, with adequate thermal insulation; but it is necessary to remark its potentially harmful effects on previously frostbitten tissue. Because of the differences observed on individual regional response to cold, thermography can be a useful tool in the frostbite prevention for subjects habitually exposed to cold environment.
| S-EPMC7326014 | biostudies-literature
Project description:ObjectiveThe aim of this study is to evaluate the efficacy and safety of a topical formulation containing lidocaine plus diclofenac (CLIFE1) compared to lidocaine (CLIFE2), to decrease pain in benign anorectal surgery (BARS) to date not evaluated. More than 50% of patients undergoing BARS, especially hemorrhoidectomy, suffer from moderate and severe postoperative pain. This remains an unresolved problem that could be addressed with the new CLIFE1 topical treatment.MethodsA multicenter, randomized double-blind, active-controlled parallel-group superiority trial, was conducted in two Spanish hospitals. Patients undergoing BARS (hemorrhoids, anal fistula and anal fissure) were randomized at the end of surgery at a 1:1 ratio to receive first dose either CLIFE1 (n = 60) or CLIFE2 (n = 60) anorectal topical treatment, and after every 12 h for the first three postoperative days and once a day from the fourth to sixth. The primary outcome was average of pain decrease after topical treatment, measured with visual analogue scale (VAS) by the patients themselves, the evening in the surgery day and four times daily for the first three postoperative days.ResultsThe results of 120 patients included out of 150 selected undergoing BARS show a decrease in pain after CLIFE1 topical treatment (7.47 ± 13.09) greater than with CLIFE2 (4.38 ± 6.75), difference -3.21 95% CI (-5.75; -0.68), p = 0.008, decreasing significantly postoperative pain ( ≥ 9 mm, VAS) in 35% of patients undergoing benign anorectal surgery, compared to 18.33 % treated with lidocaine.ConclusionsThe CLIFE1 topical treatment shows better analgesic efficacy than CLIFE2 in BARS.
| S-EPMC6250696 | biostudies-literature