Clinical Trials Directory

Trials / Completed

CompletedNCT02025153

Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain

Comprehensive Pain Programme to Determine Mechanism of Transition of Acute to Chronic Postsurgical Pain- Functional Brain Imaging, Quantitative Sensory Testing, Psychological and Genetic Screening: Prospective Cohort Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
216 (actual)
Sponsor
KK Women's and Children's Hospital · Other Government
Sex
Female
Age
21 Years – 70 Years
Healthy volunteers
Not accepted

Summary

To determine whether central sensitization is a mechanism of CPSP (chronic postsurgical pain) in women who will develop CPSP compared to women with no CPSP after hysterectomy. This mechanism is illustrated by a higher pain score in experimental pain models such as tonic heat stimulation, increased evoked mechanical temporal summation and increased wound hyperalgesia.

Detailed description

Chronic pain affects 9% of Singapore population resulting in major socioeconomic burden. Chronic postsurgical pain (CPSP) that persists for over 3 months could be related to nerve injury making this a strategic model to study the transition of acute to chronic pain. CPSP occurs in up to 50% after surgery and up to 32% after hysterectomy. Over 600000 hysterectomies were performed in the US in 2003 making CPSP a significant problem. Investigators will perform this prospective cohort study to determine whether increased central sensitization and negative psychological experience are involved in the transition of acute to chronic pain after hysterectomy. Investigators will recruit 444 women undergoing hysterectomy and employ validated physical pain testing including tonic heat stimulation, mechanical temporal summation and wound hyperalgesia which had been shown to be related to central sensitization. Pain catastrophizing (negative thoughts of pain) and state trait anxiety scoring will be assessed for the impact of negative cognitive-affective experience on CPSP. A phone survey will be performed at 4 months to determine the primary outcome of CPSP. Arterial spin labeling will be used to delineate cerebral blood flow using arterial spin labeling, functional connectivity and structural connectivity to evaluate insula-anterior cingulate cortex differences in 30 women with CPSP compared to 30 women without CPSP. In addition to evaluating whether central sensitization, negative psychological experience and activation of brain regions are different in women with CPSP after hysterectomy, the results of this study will elucidate potential mechanisms of CPSP development that will guide in future studies on potential novel therapeutic targets.

Conditions

Interventions

TypeNameDescription
OTHERpain testingphysical testing, psychological testing, genetics testing and functional brain imaging

Timeline

Start date
2013-09-01
Primary completion
2017-06-01
Completion
2017-06-01
First posted
2013-12-31
Last updated
2020-08-05

Locations

1 site across 1 country: Singapore

Source: ClinicalTrials.gov record NCT02025153. Inclusion in this directory is not an endorsement.