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

NCT02025153 | Completed DMC

• 1 other identifier: 2013/512/D
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Pain; Anaesthesia; Genetics Predisposition

Outcome Measures

Primary Outcomes (2)

• Chronic postsurgical pain (CPSP) after hysterectomy at 4 months on phone survey

  This is defined as pelvic pain (lower abdominal or perineal pain) in the last week that affected daily living during the 4 months phone survey.

  4 months post hysterectomy

• Chronic postsurgical pain (CPSP) after hysterectomy at 6 months on phone survey

  This is defined as pelvic pain (lower abdominal or perineal pain) in the last week that affected daily living during the 6 months phone survey.

  6 months post hysterectomy

Secondary Outcomes (3)

• Pain Catastrophizing Scale

  Upon recruitment till 6 months post hysterectomy

• Mechanical Temporal Summation as measured by von Frey filament

  1 day (before surgery)

• State Trait Anxiety Inventory

  1 day

Study Arms (3)

Cohort

OTHER

pain testing. All 444 subjects enrolled in the study. Subjects will receive preoperative physical (tonic heat stimulation, mechanical temporal summation and wound hyperalgesia), psychological (State Trait Anxiety Inventory, Pain Catastrophizing Scale), and genetics test; postoperative pain score assessment at 24, 48 hours; postoperative wound hyperalgesia in open abdominal hysterectomy at 72 hours; and phone survey for CPSP at 4 months.

Other: pain testing

Chronic Post-surgical Pain

OTHER

pain testing. physical testing, psychological testing, genetics testing and functional brain imaging

Other: pain testing

No Chronic Post-surgical Pain

OTHER

pain testing. physical testing, psychological testing, genetics testing and functional brain imaging

Other: pain testing

Interventions

pain testing OTHER

physical testing, psychological testing, genetics testing and functional brain imaging

Chronic Post-surgical Pain; Cohort; No Chronic Post-surgical Pain

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Anthropometric profile within the following range: age 21-70 yr, American Society of Anesthesiology status I and II women
• Benign condition such as fibroids or adenomyosis
• Abdominal or laparoscopic hysterectomy

You may not qualify if:

• Vaginal hysterectomy
• being pelvic pain
• Failure to adequately determine tonic heat stimulation and mechanical temporal summation
• History of drug dependence or recreational drug use
• Allergy to any study drugs

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

Chronic Pain; Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Susceptibility; Disease Attributes; Pathologic Processes

Study Officials

• Ban Leong Sng, Dr

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2013
• First Posted: December 31, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 5, 2020

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)