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Multimodal analgesia including pregabalin for Postoperative Pain

Phase 4

Waitlist Available

Led By Jonathan Danoff, MD

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours

Awards & highlights

Study Summary

This trial is examining whether sex affects postoperative pain following knee surgery, and whether different pain relief regimens make a difference.

Eligible Conditions

Postoperative Pain
Osteoarthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess influence of sex and multimodal analgesia regimens on acute postoperative pain scores at 48 hours postoperatively, in patients undergoing TKA.

Secondary outcome measures

Assess how sex differences and multimodal analgesia regimens influence chronic postoperative pain

Assess how sex differences and multimodal analgesia regimens influence mental health

Assess how sex differences and multimodal analgesia regimens influence physical function

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Multimodal analgesia regimen including pregabalinExperimental Treatment1 Intervention

For the pregabalin group, patient will be provided with an oral preoperative pregabalin dose of 150mg on the day of surgery. Patient will continue pregabalin 75mg two times a day, for two weeks postoperatively. For both the intervention and control groups, the operative technique and additional perioperative analgesic modalities will follow a standard protocol

Group II: Multimodal analgesia regimen not including pregabalinActive Control1 Intervention

For the non-pregabalin group, patient will be undergo total knee arthroplasty with the same operative technique and additional perioperative analgesic modalities will follow a standard protocol

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Northwell HealthLead Sponsor

458 Previous Clinical Trials

470,683 Total Patients Enrolled

4 Trials studying Postoperative Pain

372 Patients Enrolled for Postoperative Pain

Jonathan Danoff, MDPrincipal InvestigatorNorthwell Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I qualified to partake in this investigation?

"This clinical trial will accept 300 participants, aged between 18 and 80, who suffer from chronic pain. Additionally, potential patients must reside in a private home rather than an institution or rehabilitation centre; express consent to comply with the study's regulations; and remain available for its entirety."

Answered by AI

Has the FDA sanctioned Multimodal analgesia with pregabalin?

"Our safety rating of Multimodal analgesia including pregabalin is a 3, due to Phase 4 data confirming its approval."

Answered by AI

How many people have been recruited to participate in this experiment?

"Affirmative. Clinicaltrials.gov data demonstrate that this particular medical trial is actively recruiting participants, having first been posted on December 9th 2020 and last updated on July 15th 2022. It requires 300 people from a single site to take part in the study."

Answered by AI

Is the age range of participants in this study limited to individuals under 35 years old?

"This trial is accepting individuals who are within the age range of 18 to 80 years."

Answered by AI

Is this experiment seeking new participants at the present time?

"Clinicaltrials.gov provides evidence that this research project, which was first posted in December 2020 and most recently edited on July 15th 2022, is actively searching for suitable patients."

Answered by AI

Recent research and studies

British Journal of AnaesthesiaJournal

Sex Differences in Pain: A Brief Review of Clinical and Experimental Findings

Bartley, E.J., and R.B. Fillingim. 2013. “Sex Differences in Pain: A Brief Review of Clinical and Experimental Findings”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aet127.

Behavioral and Brain SciencesJournal

Sex Differences in Pain

Berkley, Karen J.. 1997. “Sex Differences in Pain”. Behavioral and Brain Sciences. Cambridge University Press (CUP). doi:10.1017/s0140525x97221485.

International Review of NeurobiologyJournal

Chapter 1 Gender Differences in Pharmacological Response

Anderson, Gail D.. 2008. “Chapter 1 Gender Differences in Pharmacological Response”. International Review of Neurobiology. Elsevier. doi:10.1016/s0074-7742(08)00001-9.

clinicaltrials.govStudy