Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02110719
Other study ID # REAG00414HU
Secondary ID
Status Completed
Phase Phase 4
First received April 7, 2014
Last updated August 15, 2016
Start date March 2014
Est. completion date June 2016

Study information

Verified date August 2016
Source Hartford Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

In recent years, there has been an emphasis on the creation of "enhanced-recovery", "fast-track" or "multi-modal" pathways to improve perioperative care (1-4). The goal of these programs is to reduce the length of hospital stay, decrease narcotic usage while improving pain control, accelerate post-operative recovery, and expedite return to baseline functional status. Pathways often are developed by a team of surgeons, nurses, pain specialists, anesthesiologists and other support staff. Postoperative components often involve multi-modal analgesia, early return to activity and early return to a regular diet. The goal of this study is to evaluate the efficacy of a multi-modal pain regimen in advanced pelvic surgery with a primary goal of decreasing narcotic usage.


Recruitment information / eligibility

Status Completed
Enrollment 138
Est. completion date June 2016
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- women >/= 18 years old

- undergoing pelvic organ prolapse or incontinence surgery with the Urogynecology department

Exclusion Criteria:

- males

- <18 years old

- women unwilling or unable to consent

- same-day-discharge surgery

- history of chronic pain for which they use medications

- current or active history of narcotic abuse

- sleep apnea

- liver or kidney dysfunction

- sulfa allergy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Celebrex

Gabapentin

IV acetaminophen

oral acetaminophen

oral ibuprofen

percocet

vicodin

Oxycodone

dilaudid

Dexamethasone

zofran


Locations

Country Name City State
United States Hartford Hosptial Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Narcotic use Narcotic use will be evaluated at all stages of the preoperative care: operating room, hospital floor and at the 1 week postoperative time point intraoperative, immediate postoperative and 1 week postoperative No
Secondary Pain pain will be evaluated at the above listed time points using the validated brief pain inventory postoperative day #1 and postoperative week #1 No
Secondary Nausea Nausea will be evaluated based on the use of narcotics in the hospital intraoperatively, postoperatively No
Secondary Constipation constipation at the time of the first bowel movement will be evaluated using the validated Bristol Stool Scale one week postoperatively No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care