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Completed

NCT Number: NCT01507493

The Impact of SCN9A Gene Polymorphism on Individual Pain Perception in the General Population

This study was conducted to explore whether the non-synonymous single-nucleotide polymorphisms in SCN9A gene can predict individual basal pain perception and postoperative pain intensity in the general population undergoing upper abdominal surgery. Methods: Patients receiving elective upper abdominal surgery under general anesthesia were recruited into this study. Genotyping of SCN9A was carried out by direct sequencing. The investigators measured their preoperative pressure pain threshold (PPT) and pressure pain tolerance (PTO). The visual analog scale (VAS) was used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 0 h, 12 h ,24 h and 48h after operation. And the PCA press frequency and drug consumption were recorded.

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Key information

Conditions

Pain Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

Patients with the following diseases were excluded: known history of chronic pain, psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy smoker, pregnancy or at the lactation period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 20-70 years
  • Receiving elective upper abdominal surgery
  • Anesthesiologists (ASA) physical status I or II
  • Received PCA administration
  • Agreed to participate the research

Exclusion criteria

  • History of chronic pain
  • Psychiatric diseases
  • Diabetes mellitus
  • Severe cardiovascular diseases
  • Kidney or liver diseases
  • Alcohol or drug abuse
  • Heavy smoker
  • Pregnancy or at lactation period
  • Refused PCA administration
  • Disagree to participate to the research

Treatment and study plan

Primary outcomes

  1. Opioid Consumption Dose 48h After Operation.

    Time frame: 48 hours after the operation

  2. PCA Press Frequency 48h After Operation.

    Time frame: 48 hours after the operation

Secondary outcomes

  1. The Visual Analog Scale 48h After Operation.

    Time frame: 48 hours after the operation

    The visual analog scale (VAS) is used for pain evaluation at rest during patient-controlled analgesia (PCA) treatment 48h after operation. And the visual analog scale is from 0 to 10 which 0 represent no pain while 10 represent unbearable pain

  2. Preoperative Pressure Pain Threshold (PPT)

    Time frame: 12 hours before the operation

    The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "pain" when they started to feel pain during the stimulation. The value from the LCD was recorded as the pressure pain threshold.

  3. Preoperative Pressure Pain Tolerance (PTO)

    Time frame: 12 hours before the operation

    The probe of pressure algometer was positioned perpendicularly to the skin surface of the patient, and the investigator applied continuous pressure at approximately the same rate according to the visual LCD display on the algometer. subjects were asked to say "ok" when they started to feel the pain became intolerable during the stimulation. The value from the LCD was recorded as the pressure pain tolerance.

Sponsors and collaborators

Lead sponsor

Xianwei Zhang

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 11, 2012
Registry last updated
Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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