Treatment Trials

132 Clinical Trials for Various Conditions

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COMPLETED
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Herniorrhaphy
Description

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after herniorrhaphy.

COMPLETED
Study of MR-107A-02 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Description

MR-107A-02 is being studied to investigate its efficacy and safety for treatment of acute pain after bunionectomy.

COMPLETED
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
Description

The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly decreases acute pain post-operatively as well as decreasing requirements of post-op opioids for pain control in PACU as compared to patients undergoing elective spine surgery without a pre-operative pain regimen.

COMPLETED
IV Acetaminophen for Acute Post Operative Pain in C-Section Patients
Description

Post-operative pain management after C-section is an important topic as the number of elective c-sections increases each year. Pain is managed either by giving opioids or by using non-opioids. The purpose of this study is to evaluate the effectiveness of IV Acetaminophen in pain relief and its impact in the usage of post-operative opioid requirements and opioid associated complications. The hypothesis is that four doses of IV Acetaminophen in conjunction with intrathecal or epidural morphine given to the patients after c-section will reduce post-operative opioid requirements and opioid associated complications.

COMPLETED
A Multicenter, Randomized, Open-Label, Parallel-Group Trial to Compare the Efficacy and Safety of the Sufentanil NanoTab PCA System/15 mcg (Zalviso™)to Intravenous Patient-Controlled Analgesia With Morphine for the Treatment of Acute Post-Operative Pain
Description

The study is intended to show that the Sufentanil NanoTab PCA System is as effective as morphine intravenous patient-controlled analgesia (IV PCA) for treating pain after surgery. Each patient will use either the Sufentanil NanoTab PCA System or morphine IV PCA to treat their pain for at least 48 hours and up to 72 hours after surgery while in the hospital.

UNKNOWN
Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients
Description

Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks. The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.

Conditions
COMPLETED
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
Description

This is an open-label, multiple-dose, safety study of DIC075V in patients with acute post-operative pain following abdominal or orthopedic surgery.

COMPLETED
Safety and Efficacy of Repeated Doses of PMI-150 (Intranasal Ketamine) in Acute Post-operative Pain Following Orthopedic Surgery
Description

The purpose of this research study is to evaluate the safety and analgesic efficacy of PMI-150 (intranasal ketamine) compared to placebo in patients with acute post-operative pain following orthopedic trauma, injury, or surgery.

COMPLETED
Safety and Clinical Utility Study of SSEC Fentanyl 40 mcg for Acute Post-op Pain Management in Pediatric Participants
Description

The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.

WITHDRAWN
A Feasibility Dose-escalating Study of MDT-10013 for Acute Postoperative Pain Following Total Knee Arthroplasty
Description

This is an open-label dose-escalating study to evaluate the tolerability and systemic exposure of MDT-10013 in men and women at least 18 years of age who are undergoing primary unilateral TKA.

COMPLETED
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction
Description

The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary objectives were to compare each valdecoxib dose with placebo on additional measures of pain intensity, health outcomes, the use of rescue medication, and the occurrence of opioid-related symptoms, and to evaluate their safety.

Conditions
TERMINATED
Safety of Buprenorphine Transdermal System (BTDS) in Subjects With Acute Postoperative Pain After Total Knee Replacement
Description

The objectives in this study are to evaluate: (1) efficacy of buprenorphine transdermal system (BTDS, Butrans™) on postoperative pain following total knee replacement surgery; (2) the impact of BTDS on functional rehabilitative measures after total knee replacement surgery; and 3) the safety of BTDS after total knee replacement surgery. The double-blind treatment period is for 28 days during which time supplemental analgesic medication will be provided to all subjects in addition to study drug. Purdue Pharma L.P. terminated the trial early due to administrative reasons not related to efficacy or safety. The focus of this study became safety evaluations.

COMPLETED
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
Description

The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.

Conditions
COMPLETED
Evaluate the Efficacy and Safety of ACP-044 for the Treatment of Acute Postoperative Pain Following Bunionectomy
Description

To evaluate the efficacy of ACP-044 compared with placebo in the treatment of acute postoperative pain

COMPLETED
Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in the Management of Acute Postoperative Pain
Description

Evaluate the Safety and Pharmacokinetic Profile of CPL-01 in patients after mini-abdominoplasty

Conditions
COMPLETED
RelieVRx for Total Knee Arthroplasty (TKA) for the Reduction of Acute Postoperative Pain and Opioid Use
Description

This is a single-center, prospective, randomized, controlled study of the appliedVR RelieVRx headset in subjects undergoing Total Knee Arthroplasty (TKA). This study will evaluate two primary endpoints - effectiveness of a single use of RelieVRx in the reduction of acute postoperative pain by 20%; and overall effectiveness of RelieVRx as an opioid-sparing intervention, where opioid consumption is reduced by at least 20% over a 90-day postoperative period in the interventional, standard of care (SOC) plus RelieVRx group compared to the control, SOC group.

COMPLETED
A Study of MDT-10013 in the Treatment of Acute Postoperative Pain Following Bunionectomy
Description

The purpose of this study is to evaluate the efficacy and safety of MDT-10013 in men and women 18 to 80 years of age who are undergoing bunionectomy. The primary objective is to determine the analgesic efficacy of MDT-10013 compared with standard of care in the treatment of acute postoperative pain after subjects undergo bunionectomy.

COMPLETED
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Description

When post-operative parenteral analgesia is discontinued, oral dosing with study medication may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS (pain intensity score greater than or equal to 40). This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer promotes opioids and no longer markets Opana® ER.

RECRUITING
A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
Description

The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are: 1. How much of the investigational product is absorbed in the blood? 2. Are there side effects?

ACTIVE_NOT_RECRUITING
Intravenous Methocarbamol for Acute Pain After Spine Surgery
Description

The goal of this target trial emulation is to evaluate the impact of intravenous (IV) methocarbamol on postoperative pain and opioid use in adults undergoing elective spine surgery. The main questions it aims to answer are: * Does IV methocarbamol reduce pain in the 6 hours following surgery? * Does IV methocarbamol decrease the need for opioid pain medications in the same period? Participants who receive IV methocarbamol as part of their routine postoperative care will have their pain scores and opioid consumption tracked for 6 hours after treatment. Pain levels will be measured using standard assessments, and opioid use will be quantified in oral morphine equivalents.

TERMINATED
Duloxetine Impact on Postoperative Pain Control and Outcomes
Description

1. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative narcotic consumption. 2. Evaluate differences between patients taking Duloxetine or placebo following lateral lumbar interbody fusion for postoperative pain, function, and quality of life. 3. Evaluate the correlation between preoperative screening tests (measuring pain centralization, anxiety, depression, and overall function) and patients' response to treatment (reduction in pain, anxiety, or depression and improvement in function).

TERMINATED
Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ST-2427
Description

This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.

RECRUITING
This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars
Description

The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are: Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours? Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain. Participants will: Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up. Report the pain relief during the 12 hours after dosing to record changes in the post-operative pain

COMPLETED
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
Description

This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo. The primary objective of the trial is to establish the analgesic efficacy of co-crystal E-58425 by demonstrating a superior effect compared to tramadol and to celecoxib for the management of moderate to severe acute post-operative pain for 48 hours after bunionectomy.

NOT_YET_RECRUITING
Dispersion Following ESP Versus ITP Blocks Using Lidocaine Study
Description

Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the chest wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. Alternative peripheral nerve block techniques, such as intercostal nerve blocks, eliminate the neuraxial complications but, in turn, require numerous injections to provide unilateral coverage. The introduction of ultrasound-guided (USG) nerve blocks has generated clinical interest in the development of novel paraspinal (non-epidural) nerve block techniques, which will provide multiple dermatomal coverage with a single injection. Two such techniques are the Erector Spinae Plane (ESP) block and the Intertransverse Process (ITP) block. The Intertransverse Process (ITP) block targets a slightly deeper plane than the Erector Spinae Plane (ESP) block and was specifically designed to address the ESP block's variable anesthetic spread. Despite its potential for more localized and precise dermatomal coverage, no prior studies have directly compared the two techniques in terms of their cutaneous distribution. Thus, this randomized, double-blinded trial aims to compare the cutaneous distribution of both these blocks in healthy adult volunteers. To compare the dermatomal sensory block distribution, the investigators will use detailed mapping with pinprick, cold, and heat stimuli. In addition to assessing the distribution and coverage of the ESP and ITP blocks, this study also seeks to investigate the pharmacokinetics (PK) of lidocaine in each technique. The rationale for this lies in the anatomical differences between the two blocks. Theoretically, there may be a difference in the anatomical target for both blocks, but the investigators hypothesize that there is no difference in the local anesthetic absorption. Therefore, the investigators expect similar systemic absorption, the chances of local anesthetic systemic toxicity (LAST) should be equally low, and both blocks should be similarly safe. A total of 14-18 healthy adult volunteers will be included. There will be two different procedure days, separated by at least one week. On each day, the subjects will receive a paraspinal block, according to the randomization process. Each volunteer will undergo pre-procedure screening on the first visit. The blocks will be performed on the same side, at the same level, by the same anesthesiologist, at least one week apart. An ultrasound-guided ESP block will be administered in one day, and an ITP block on the other. The order will be randomized, and both the subject and the research team member assessing the block will be blinded. Sensory testing will be performed at baseline and 60-90 minutes after the block injections. Serial samples of blood will be drawn to analyze lidocaine PK (between 0 and 240 minutes post-block).

TERMINATED
Multicenter Study to Compare Intravenous and Oral Acetaminophen for the Treatment of Acute Moderate to Severe Pain
Description

The purpose of this study is to compare intravenous (IV) and oral acetaminophen for the treatment of acute moderate to severe pain in combination with standard patient-controlled analgesia (PCA) in adult subjects following total knee replacement.

COMPLETED
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Description

The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

COMPLETED
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
Description

The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.

COMPLETED
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Description

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.

COMPLETED
Ketorolac on Postoperative Pain Reduction in Pediatric Patients with Adenotonsillectomy
Description

Postoperative pain management in the pediatric patient undergoing tonsillectomy is challenging. Despite being used in many procedures for postoperative pain management, perioperative ketorolac usage in pediatric tonsillectomy surgery is very limited. A recent survey showed that only 8.2% of anesthesiologists use NSAIDS for perioperative management of children with OSA undergoing adenotonsillectomy. The investigators propose to conduct a prospective, randomized study to investigate the opioid-sparing effect of perioperative ketorolac in pediatric patients who undergo tonsillectomies.