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Completed

NCT Number: NCT03913650

The Influence of Peripheral Nerve Blocks in Patients Undergoing Limb Orthopedic Surgery

To investigate pre-op peripheral nerve block in reducing peri-op IL-6 level and post-op pain

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Key information

Conditions

Pain, Postoperative Change; Circulatory Intraoperative Complications Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgical Injury

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I-Cheng Lu, Kaohsiung City, Taiwan

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About this study

In orthopedic surgery, peripheral nerve block can be used as an anesthesia adjuvant prior to surgery. In this study, we hypothesized that peripheral nerve blocks may alleviate inflammatory response and reduce the analgesics requirement. Sixty patients undergoing limb orthopedic surgery will be enrolled. Peripheral nerve block was injected with 0.25% bupivacaine under ultrasound guidance. 30 patients (Study group) underwent surgery with nerve blocks and another 30 patients (Control group) underwent surgery with morphine. The anesthetic protocol was standardized for both groups by experienced anesthesiologists. Surgical stress was assessed by blood pressure fluctuation and proinflammatory cytokine. Pain intensity was measured by numeric rating scale (NRS) score for 24 hours

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of limb fracture
  • must receiving orthopedic surgery

Exclusion criteria

  • With the comorbidity of chronic heart, lung, liver and renal disease, Chronic alcoholism, Allergy to bupivacaine

Treatment and study plan

0.25% bupivacaine

Procedure

nerve block procedure will be decided by patients' will for post-op pain

Other names: nerve block with 0.25% bupivacaine

Primary outcomes

  1. peak pain intensity in the postoperative care unit

    Time frame: 2 hours

    pain score evaluated by pain score

Secondary outcomes

  1. change of perioperative IL-6 level

    Time frame: up to 6 hours

    blood samples assessed by ELISA

Other outcomes

  1. changes of perioperative hemodynamic parameter

    Time frame: up to 3 hours

    heart rate

  2. changes of perioperative hemodynamic parameter

    Time frame: up to 3 hours

    blood pressure

Sponsors and collaborators

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Other

Collaborators

  • Kaohsiung Municipal Hsiaokang Hospital

Registry information

Official study title

Preoperative Peripheral Nerve Blocks Attenuate Intraoperative Surgical Stress and Postoperative Pain in Patients Undergoing Orthopedic Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2019
Registry last updated
Feb 18, 2020

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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