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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913650
• Other study ID #: KMUH-IRB-F(I)-20170007
• Status: Completed
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2020
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Change; Circulatory
• Intraoperative Complications
• Pain, Postoperative
• Surgical Injury

Intervention

Procedure:
• 0.25% bupivacaine
nerve block procedure will be decided by patients' will for post-op pain

Locations

Country	Name	City	State
Taiwan	I-Cheng Lu	Kaohsiung
Taiwan	Kaohsiung Municipal Siaogang Hospital	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung Municipal Hsiaokang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	changes of perioperative hemodynamic parameter	heart rate	up to 3 hours
Other	changes of perioperative hemodynamic parameter	blood pressure	up to 3 hours
Primary	peak pain intensity in the postoperative care unit	pain score evaluated by pain score	2 hours
Secondary	change of perioperative IL-6 level	blood samples assessed by ELISA	up to 6 hours