Treatment Trials

23 Clinical Trials for Various Conditions

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COMPLETED
Single Port Insufflation RCT
Description

The goal of this clinical trial is to learn if decreasing insufflation pressure during minimally invasive single port robotic sacrocolpopexy improved postoperative pain without impacting surgeon intraoperative visualization. The main question it aims to answer is: Does minimally decreasing insufflation pressure improve postoperative pain? Researchers will compare standard insufflation pressure (15 mmHg) to experimental insufflation pressure (12 mmHg) to see if it insufflation pressure impacts patient's postoperative pain. Once a participants agrees to participate in our study, they will receive either standard or experimental pressure at the time of surgery. Postoperative pain scores in the postoperative anesthesia care unit and at postoperative day 1 and 14 visits will be recorded. Participants will also be asked to complete the Patient Global Impression of Improvement at the 14 day visit.

COMPLETED
A Trial of the Cost Effectiveness of IV Acetaminophen in Bariatric Surgery
Description

Bariatric surgery is the only proven and effective long term treatment for morbid obesity. In an attempt to reduce patients' post-operative hospital stay, lower associated health care costs, and improve satisfaction scores, St Luke's University Health Network (SLUHN) recently adopted a fast track bariatric surgery (FTBS) protocol. Findings to date show that FTBS is safe and effective when performed in a Center of Excellence (COE) such as ours. However, post-operative pain control remains a challenging issue, with only intravenous (IV) or PO (by mouth) narcotics appropriate for bariatric surgery patients. IV acetaminophen, which has been used successfully in Europe, was recently approved by the Federal Drug Administration (FDA) for use in the US. However, no data exist regarding the use of IV acetaminophen in bariatric surgery patients, nor are there any data assessing its cost effectiveness. Therefore, our study will investigate the economic impact of administering IV acetaminophen to bariatric surgery patients, as well as its effect on clinical outcomes such as patients' post-operative length of stay, self-reported pain, readmissions, emergency room (ER) visits and complications. The study design will be a randomized, double-blind, parallel-group, controlled trial in a single bariatric Center of Excellence (COE) that is part of the St. Luke's University Health Network (SLUHN). Patients will consist of up to 200 morbidly obese adult bariatric surgery candidates \> 18 years of age undergoing either laparoscopic Roux-en-Y Gastric Bypass (LRYGB) or laparoscopic Sleeve Gastrectomy (LSG). Group 1 (treatment) will receive IV acetaminophen plus IV narcotics for the first 6 hours post-surgery followed by IV/ PO narcotics for the remaining 18 hours. Group 2 (control) will receive IV normal saline plus IV narcotics for the first 6 hours post-surgery followed by IV/PO narcotics for the remaining 18 hours. Data analysis will include quantile regression, mixed randomized-repeated analysis of covariance (ANCOVA) and selected univariate comparisons, with p \< .05 denoting statistical significance for all outcomes.

TERMINATED
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy
Description

The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

TERMINATED
Comparison of Anesthetic Techniques on Total Hip Arthroplasty
Description

To compare analgesia and orthopedic rehabilitation milestones in patients receiving either spinal anesthesia (local anesthetic plus opioid) or general endotracheal anesthesia with lumbar plexus block.

Conditions
TERMINATED
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
Description

The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.

Conditions
COMPLETED
Evaluation of Dexmedetomidine on Post-operative Narcotic Requirements and Pain Scores in Bariatric Patients
Description

The purpose of the study is to determine whether a single bolus dose of dexmedetomidine administered during bariatric surgery has any effect on the amount of narcotic pain medications required by an individual after surgery. Patients who undergo weight loss surgery will be randomized into two groups - group one -dexmedetomidine group and group two- control group. Both groups will receive a standard anesthetic. Control group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and 60ml saline. Experimental group will receive weight based dose of fentanyl (standard narcotic pain reliever), intravenous acetaminophen (non-narcotic pain reliever), and dexmedetomidine (given as 1mcg/kg over 10 minutes Intravenous). The Patient will then awaken after surgery in post anesthetic recovery unit and be given a patient controlled analgesia (PCA) pump with hydromorphone (long acting narcotic pain reliever). The amount of hydromorphone used will be recorded by the PACU nurse to the electronic health record ( routine practice) in the two groups and compared for pain medicine requirements. Secondary endpoints will be Visual Analog Score (VAS) pain score, respiratory rate, heart rate, blood pressure oxygen saturation and respiratory rate. All will be recorded at 30,60,90,120 and 240 minutes in the electronic medical record in PACU and compared between the two groups . All the data - Intra operative and Post -operative - Post Anesthesia Care Unit ( PACU) data will be retrieved from the electronic Medical record (EMR). All intra-operative data is automatically computed into the patients EMR. All PACU data is routinely entered into the EMR by the PACU nurse including the PCA data.

Conditions
NOT_YET_RECRUITING
Evaluation of Pain Management After Surgery When Using Exparel in the Pediatric Population
Description

The goal of this randomized clinical trial is to determine if administration of Exparel via local infiltration for medial patellofemoral ligament (MPFL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does Exparel significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does Exparel significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of patients who receive Exparel and Marcaine via local infiltration to those of patients who receive only Marcaine via local infiltration for their MPFL reconstruction surgery. The goal is to understand if there is a significant difference in patient pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either Exparel + Marcaine intraoperatively or Marcaine only intraoperatively during their MPFL reconstruction surgery * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their MPFL reconstruction surgery at postoperative day 1

NOT_YET_RECRUITING
Evaluation of Pain Management After Surgery When Using Nerve Blocks in the Pediatric Population
Description

The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery. * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1

RECRUITING
IPACK on Early Pain Scores After ACL Reconstruction
Description

The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are: * if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery * if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery. Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to. Researchers will compare self-reported pain scores and short-term opioid use of all study participants.

COMPLETED
No Opioids PrescrIptions On Discharge After Surgery
Description

Opioid analgesics are routinely prescribed for these patients for post-operative pain control. Even a short exposure to opioids in opioid-naïve patients following minor or major surgery has been associated with de novo habitual or persistent use of opioids in 5-30% of patients. The goal of the study to eliminate the use of outpatient opioids prescriptions after major urologic surgery.

UNKNOWN
Use of Analgesics and Pain Scores After Pediatric Adenotonsillectomy
Description

The purpose of the study is to quantify the use of pain medications given to children aged 3 - 12 years as well as their pain level through pain scores after they have undergone a tonsillectomy or adenotonsillectomy surgery at Doernbecher Children's Hospital (DCH). We would like to learn more about the pain medications given and the pain scores of children post-surgery for the first 5 days following discharge from the hospital.

WITHDRAWN
Study to Evaluate a Preop Dose of Brivoligide Injection for Pain After Knee Replacement in Patients With High PCS Scores
Description

This is a multi-center, Phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of brivoligide injection administered intrathecally before surgery in patients with a Pain Catastrophizing Scale (PCS) score ≥16 undergoing primary unilateral total knee arthroplasty.

UNKNOWN
Study to Determine if Pre- and Post- Operative TAP Catheters With Ropivacaine Versus Placebo Affects Anesthetic, Narcotic Dosing, and Pain Scores
Description

A randomized controlled trial to determine if pre- and post- operative regional pain control (transversus abdominis plane block) with ropivacaine versus placebo leads to lower anesthetic and narcotic dosing, and alters pain scores. This study plans to learn more about regional anesthesia and pain control during abdominal surgery. The study will gather data about the effectiveness of continuous catheter infusion of local anesthetic after an abdominal operation. Outcomes include pain scores, IV pain medicine requirements, and delirium.

COMPLETED
Minimizing Post-surgical Pain and Narcotic Administration Through Cryotherapy
Description

Postoperative pain is an unavoidable consequence of open abdominal surgery. Although cryotherapy, the application of ice to a surgical wound site, has been shown to be effective in reducing postoperative pain in orthopedic, gynecologic, and hernia operations, it has not been assessed in patients who undergo major open abdominal operations. We hypothesized that patients who receive cryotherapy would report lower pain scores as a primary outcome measure. This would result in less narcotic analgesia usage, and shorter hospital stays as secondary outcome measures.

RECRUITING
Pudendal vs Caudal Block for Pediatric Penile Surgery
Description

The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.

COMPLETED
Continuous Subpleural Infusion of Bupivacaine
Description

Rationale: For the past 3 years the investigators have routinely used an axial subpleural tunneling technique that del Study Design: All patients over the age of 18 having an isolated thoracoscopic procedure performed at Inova Fairfax Hospital for therapeutic or diagnostics purposes will be screened. Patients will be excluded if they have: previous ipsilateral thoracic surgery, need for operative pleurectomy or pleurodesis, chronic use of pain medication, sedatives or hypnotics, drug allergies, liver dysfunction, renal dysfunction, history of peptic ulcerative disease, sleep apnea in need of Bipap, severe chronic obstructive pulmonary disease (COPD), inability to consent, or are pregnant. All patients included will be screened, consented, and operated on by the one year anniversary of institutional review board (IRB) approval. Study Methodology: Eighty-six consented patients will be randomized into the study arm (use of a pain catheter with 0.125% bupivacaine) or the standard of care group (no pain catheter). The primary outcome is the use of narcotic pain medication post-operatively, compared between study groups. Secondary outcomes will include postoperative pain scores, hospital and length of stay. The On-Q pump delivers local anesthetic to the intercostal space, without leakage elsewhere, creating a functional multi level rib block. Despite positive subjective results, objective data is lacking. The investigators have also noted that some patients develop an annoying short term paresthesia that has been minimized by using lower anesthetic concentrations than described in other publications. Objectives: To evaluate visual analog pain scores post-operatively up to 30 days post-operative, and to determine any association between pain management and length of stay. Study Type: A prospective randomized 2-arm study will be performed. Statistical Methodology: Total amount of narcotic pain medication administered through postoperative day 7, will be compared between the study groups using student's t-tests and Wilcoxon rank-sum tests. Secondary outcomes, overall sum of pain scores through postoperative day 7, then at day 30 post-operatively, hospital length of stay, and overall hospital cost, will also be compared among study groups using student's t-tests and Wilcoxon rank-sum tests.

WITHDRAWN
Duloxetine Tibial Plateau
Description

The purpose of this study is to determine if Duloxetine provides effective pain management for adult patients (18 or older) undergoing tibial plateau surgery. Participants from two institutions will be randomized to one of two treatment groups: control (Group A) and treatment (Group B). Group A control group will receive placebo of sugar pill and BMC standard of care - namely postoperative, IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump (BMC standard of care). Group B, the intervention group, will receive three doses of 60 mg of oral duloxetine (right before operation, postop day 1, postop day 2). This study is important as tibial plateau surgery's postoperative pain management primarily involved providing opioids, and if duloxetine can result in reduced narcotic intake and lower pain scores, it can potentially improve patient care, rehabilitation, early movement, and shorter length of hospital stay.

WITHDRAWN
Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
Description

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to local infiltration done in adult patients having wrist arthroscopy surgery. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

TERMINATED
Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair
Description

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.

COMPLETED
Single Shot vs 24hr vs 48hr Continuous Adductor Canal Block After TKA
Description

The purpose of this study is to compare a single shot block, 24 hours, and 48 hour continuous catheter nerve block done via the adductor canal method in adult patients who have under gone total knee arthroplasty. Visual analogue scores, opioid consumption, time to up and go, ambulation, manual muscle tests, and Tinetti scores up to 72 hours post operatively will be used for comparison.

RECRUITING
Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies
Description

Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.

Conditions
WITHDRAWN
Transverse Abdominal Plane Anesthesia for Abdominal Wall Reconstruction
Description

The aim of this study is to evaluate the short-term postoperative outcomes in the abdominal wall reconstruction population using an intraoperative local anesthetic infusion. A prospective randomized double blind study of patients undergoing component separation will be performed in order to assess the following outcomes: 1. Length of Stay (LOS) 2. Return of bowel function 3. Narcotic pain medication requirements 4. Nausea and emesis 5. Pain scores

Conditions
COMPLETED
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial
Description

The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.