A Combined Nerve Block in Elderly Patients Subjected to Total Hip Replacement

NCT02884388 | Unknown DMC

• 1 other identifier: QinghaiUH_002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to validate the hypothesis that a combined nerve block produces better outcomes including intraoperative stress, hemorrheological indexes, postoperative immune function, and incidence of postoperative complications than general anesthesia.

Conditions

Arthropathy of Hip

Outcome Measures

Primary Outcomes (1)

• Intraoperative serum cortisol concentration

  To evaluate intraoperative stress response. The normal serum cortisol concentration is 138-635 nM measured at 8:00 a.m.-10:00 a.m. and 83-359 nM at 4:00 p.m.-6:00 p.m. Greater intraoperative serum cortisol concentration indicates stronger stress response.

  during surgery

Secondary Outcomes (3)

• Serum cortisol concentration

  prior to anesthesia, prior to and immediately after surgery

• Blood glucose level

  prior to anesthesia, prior to, during and immediately after surgery

• Incidence of adverse events

  1, 3, 7 days and 3 months after surgery

Study Arms (2)

experimental group

EXPERIMENTAL

Combined nerve block will be used, involving lower lumbar plexus, sciatic nerve, and paraspinal nerve L1-2.

Procedure: combined nerve block

control group

EXPERIMENTAL

General anesthesia will be used in this group.

Procedure: general anesthesia

Interventions

combined nerve block PROCEDURE

Patients in this group were assigned to receive lower lumbar plexus block, sciatic nerve block, and paraspinal nerve L1-2 block.

Also known as: experimental group

experimental group

general anesthesia PROCEDURE

Patients in this group were assigned to receive general anesthesia.

Also known as: control group

control group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Blood pressure below 160/90 mmHg (1 mm = 0.133 kPa)
• Hemoglobin \> 90 g/L
• Fasting blood glucose level \< 10 mM
• Preoperative examinations (blood, urine, stool tests, hepatic and renal function, blood coagulation, electrolyte level and electrocardiogram): normal
• Type I-II in American Society of Anesthesiology (ASA) classification
• Age \> 65 years
• Of either sex
• Provision of signed informed consent to participate in the trial

You may not qualify if:

• Severe heart, liver, lung, kidney or hematological system diseases, severe infection or malignant tumor
• Allergy to anesthetic agents
• Are taking immunosuppressive agents and/or glucocorticoid
• Viral infections
• Mental disorder, dysnoesia, hearing disorder or poor compliance during the anesthesia
• Alcohol or drug abuse

Sponsors & Collaborators

• Qinghai University: lead

Study Sites (1)

Qinghai University Affiliated Hospital

Xining, Qinghai, 810001, China

RECRUITING

MeSH Terms

Interventions

Anesthesia, General; Control Groups

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Liangde A, Master

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liangde A, Master

CONTACT

8618009782881; liangdea_qu@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 31, 2016
• Study Start: December 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

CN (1)