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Postsurgical Pain clinical trials

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NCT ID: NCT06412380 Completed - Postoperative Pain Clinical Trials

Influence of Insertion Torque and Bone Type on Post-operative Pain

Start date: December 1, 2019
Phase: N/A
Study type: Interventional

The objectives of this clinical study were to assess the effect of different ITs and bone types on POP levels and survival rates and to investigate the effect of different patient- and site-related factors on POP levels and survival rates.

NCT ID: NCT06344169 Not yet recruiting - Cesarean Section Clinical Trials

Dinalbuphine Ester (Naldebain) for Pain Management After Cesarean Section

Start date: April 15, 2024
Phase: Phase 2/Phase 3
Study type: Interventional

Inadequate postoperative pain management can lead to physical and psychological distress in patients as well as impact surgical wound healing and increase the risk of developing postoperative delirium and cardiopulmonary and thromboembolic events. Severe postoperative pain may also result in the development of chronic post-surgical pain (CPSP), which in turn can lead to prolonged use of opioids and increased health-care costs. A descriptive survey study in 60 postpartum women who received cesarean section suggested that the presence of postoperative pain significantly reduced the willingness of breastfeeding and infant care. The incidence of CPSP after cesarean delivery has been reported to vary from 1% to 18% up to 1 year after operation. Intrathecal morphine (ITM) injection is considered as the standard pain management strategy for post-cesarean pain. However, the overall analgesic effect of ITM is about 8-12h and it is associated with pruritus, nausea/vomiting, urinary retention, constipation, mental status change, and respiratory depression. Therefore, the development of a safe, conveniently operated, and long-lasting analgesic strategy, which serves as background pain control modality up to several days after cesarean section should provide clinically beneficial advantages in the management of acute postoperative pain and prevention of CPSP in postpartum women. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. The bioavailability of nalbuphine following intramuscular injection Naldebain® was 85.4%, and it took approximately 6 days for the complete release of Naldebain® into the blood circulation. Therefore, a single parenteral injection of Naldebain® could provide long lasting analgesic effect in several phase II trials. However, Naldebain® has not been tested in the pain control after cesarean section. Therefore, this PI-initiated prospective, randomized, open-label, non-inferiority trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in term parturient who receive elective cesarean section to provide analgesic effect that is not inferior to the standard ITM and prevent the development of CPSP.

NCT ID: NCT06202989 Not yet recruiting - Postsurgical Pain Clinical Trials

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Start date: January 2024
Phase: Phase 3
Study type: Interventional

Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty. Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.

NCT ID: NCT05698914 Recruiting - Clinical trials for Chronic Low-back Pain

Telehealth Mindfulness After Spine Surgery

Start date: February 22, 2023
Phase: N/A
Study type: Interventional

The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative spine condition. The study aims to answer the following questions: 1. Is it feasible and acceptable to deliver the interventions and conduct the study procedures in this patient population? 2. Do the interventions benefit patients with regard to pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery, and does one intervention have more benefit than the other? Participants will be asked to do the following: 1. Complete self-report questionnaires online before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 2. Complete a sensory pain task before spine surgery, and around 2 weeks, 3 months, and 6 months after spine surgery. 3. Around two weeks after surgery, participants will be randomly assigned by chance to one of two behavioral interventions - Mindfulness or Education. Participants will then be asked to attend 8, weekly sessions with a study treatment coach over telehealth (online with camera and microphone).

NCT ID: NCT05607641 Completed - Postsurgical Pain Clinical Trials

Efficacy and Safety Study of Ketorolac / Pitofenone / Fenpiverinium for the Treatment of Patients With Pain After Surgical Abdominal and Pelvic Operations

Start date: July 7, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Neospastil (ketorolac tromethamine / pitofenone hydrochloride / fenpiverinium bromide fixed-dose combination) in a form of solution for injections and film-coated tablets has been studied as a treatment for pain after surgical abdominal and pelvic operations. The aim of the study was to test the hypothesis that Neospastil was non-inferior (phase II) and superior (phase III) than ketorolac tromethamine monotherapy due to the additional relaxing effect of pitofenone and fenpiverinium on the smooth muscles of internal organs. The study also aimed to show that Neospastil is safe and well-tolerated in people who have pain after surgical abdominal and pelvic operations. Study treatment was initiated with parenteral form of study drug (first 24 hours) and then switched to oral formulation. This trial was conducted in accordance with the ethical principles of Good Clinical Practice and International Council for Harmonization (ICH) Harmonized Tripartite Guidelines.

NCT ID: NCT05394402 Recruiting - Postsurgical Pain Clinical Trials

A Trial of SHR0410 Injection in Postsurgical Pain Management

Start date: August 9, 2022
Phase: Phase 2
Study type: Interventional

The study is being conducted to evaluate the efficacy, safety of SHR0410 Injection and to explore the reasonable of SHR0410 Injection for Pain Management after Orthopaedic Surgery.

NCT ID: NCT05193227 Recruiting - Postoperative Pain Clinical Trials

Sustained Release Lidocaine for the Treatment of Postoperative Pain

Start date: October 27, 2021
Phase: Phase 2
Study type: Interventional

In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.

NCT ID: NCT04774328 Completed - Postsurgical Pain Clinical Trials

Preliminary Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

Start date: September 9, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

A Three-Part, Phase 1/2, Randomized, Double-blind, Placebo-Controlled, Adaptive Safety, Pharmacokinetics, and Preliminary Efficacy Study of CA-008 (Vocacapsaicin) in Patients Undergoing Ventral Hernia Repair

NCT ID: NCT04681027 Suspended - Chronic Pain Clinical Trials

Safety, Tolerability, Effectiveness, and Pharmacokinetic Data in Opioid-experienced Children

Start date: March 11, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study was to assess the safety and pharmacokinetics (single- and multiple-dose) of oxymorphone ER for the relief of moderate to severe pain in pediatric participants ages 7 - ≤17 years old requiring a continuous, around-the-clock (ATC) opioid treatment for an extended period.

NCT ID: NCT04648683 Completed - Opioid Use Clinical Trials

Postoperative Telehealth Mindfulness Intervention After Spine Surgery

Start date: December 21, 2021
Phase: N/A
Study type: Interventional

Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States. Rates of spine surgeries performed to address degenerative spine conditions have increased markedly. A subset of patients experience poor pain, functional, or quality of life outcomes after surgery. This study will adapt and evaluate the feasibility and potential benefits of both a one-on-one and a group-delivered, face-to-face telehealth, mindfulness intervention for patients recovering from lumbar spine surgery. The goals of the intervention are to improve short and long-term pain management, reduce the need for long-term pain medications, and improve physical and psychological well-being after surgery. The study will result in a refined intervention manual based on feasibility, participant exit interviews and satisfaction surveys which will be piloted in a future randomized controlled trial.