CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 104 enrolled
Drug / intervention
Ketaminedrug
Likely dose
Ketamine 0.5mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01243801
NCT01243801Phase 4Completed

Phase 4 Study of Prevention of Persistent Postsurgical Pain After Thoracotomy Using Ketamine

Hospital Clinic of Barcelona·interventional·Posted Nov 19, 2010·Updated Mar 23, 2015

In Brief

A Phase 4 clinical trial evaluating Ketamine for Persistent Pain and Postoperative Hyperalgesia. Completed, enrolled 104 participants across 2 sites.

Detailed Summary

Postthoracotomy acute pain is followed by persistent postsurgical pain in 20-30% of the patients, defined as pain that lasts more than 3-6 months after surgery. Acute pain and hyperalgesia around the surgical wound are some of the risk factors associated to the development of chronic pain. Ketamine, as a NMDA antagonist mainly at spinal level, might reduce periincisional hyperalgesia and persistent postsurgical pain after thoracotomy. Therefore, the investigators hypothesized that continuous ketamine infusion at subanesthetic dose would potentiate epidural ropivacaine and fentanyl-induced analgesia after thoracotomy, reduce periincisional hyperalgesia and long-term postoperative pain. To test these hypothesis, the investigators administered a low dose of intravenous ketamine or epidural ketamine or placebo to patients who received an epidural infusion of ropivacaine and fentanyl for postthoracotomy pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 19, 2010
Enrollment StartSep 1, 2008
Primary CompletionOct 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 15.6 years ago

Interventions

Ketaminedrug

Intravenous ketamine 0.5mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h Epidural Ketamine 0.5 mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h