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The Assessments of the Postoperative Recovery on Elderly Patients Received General Anesthesia or Peripheral Nerve Blocks

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Junle Liu, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01782612
First Posted: February 4, 2013
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Junle Liu, Chinese PLA General Hospital
  Purpose
Postoperative recovery is always worrisome to the elder patients undergoing Total Hip Replacement (THR). Peripheral Nerve Blocks (PNBs), lumbar plexus block combined with sciatic nerve blocks, may be alterative anaesthesia style to the fragile patients. But pervious papers suggested PNBs were commonly administered in conjunction with general anesthesia (GA), or the blocks were performed primarily for postoperative analgesia. Hardly any research has reported in use of Peripheral Nerve Blocks (PNBs) as primary anesthesia style for Total Hip Replacement (THR). The investigators compare peripheral nerve blocks to general anesthesia on elderly eld patients undergoing Total Hip Replacement (THR) by assessing the Postoperative Recovery and Delirium

Condition Intervention
Anesthesia Hip Osteoarthritis Procedure: Multimodal analgesic techniques Procedure: Total uni-Hip Replacement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Comparison of Peripheral Nerve Blocks With General Anesthesia on Elderly Patients Undergoing Total Hip Replacement (THR) by Assessing the Postoperative Recovery and Delirium

Resource links provided by NLM:


Further study details as provided by Junle Liu, Chinese PLA General Hospital:

Primary Outcome Measures:
  • Postoperative recovery by the Post-operative Quality Recovery Scale (PQRS) [ Time Frame: 7days ]

Secondary Outcome Measures:
  • Postoperative Delirium [ Time Frame: 72 hours ]

Other Outcome Measures:
  • Cardiovascular and Pulmonary complications [ Time Frame: 7 days ]
  • Stress and Inflammation [ Time Frame: 7 days ]

Estimated Enrollment: 100
Study Start Date: March 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: General Ansethesia
Subjects undergoing Total uni-Hip Replacement will receive standard General Anesthesia with Laryngeal Mask Airway and Multimodal analgesic techniques
Procedure: Multimodal analgesic techniques
Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.
Procedure: Total uni-Hip Replacement
All subjects will undergo standard Total uni-Hip Replacement
Experimental: Peripheral Nerve Blocks
Subjects undergoing Total uni-Hip Replacement will receive Lumbar plexus block and Sciatic nerve block with 0.4% Ropivacaine and Multimodal analgesic techniques
Procedure: Multimodal analgesic techniques
Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.
Procedure: Total uni-Hip Replacement
All subjects will undergo standard Total uni-Hip Replacement

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 75years old
  • Undergoing primary total uni-hip arthroplasty surgery
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Mini-Mental score examination (MMSE) being more than 23

Exclusion Criteria:

  • Patient refusal to participate in the study
  • Failure of regional block
  • Insulin dependent diabetes
  • Allergic to local anesthetics or general anesthetics
  • History of opioid dependence
  • Contraindications to nerve blocks (coagulation defects, infection at puncture site, preexisting neurological deficits in the lower extremities)
  • Patient refusal to participate in the study
  • Current severe psychiatric disease or alcoholism or drug dependence
  • Severe visual or auditory disorder
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01782612


Contacts
Contact: Zhang Hong, Ph.D 0086-10-66937462 mazuimao301@yahoo.com.cn
Contact: Wang XiaoLin, M.D 0086-10-66938059 wangxiaol1025@yahoo.com

Locations
China, Beijing
Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Zhang Hong, Director    0086-10-66937462    mazuimao301@yahoo.com.cn   
Contact: Wang Xiaolin       wangxiaol1025@yahoo.com   
Sub-Investigator: Gong Maowei         
Sub-Investigator: Zhao Ying         
Sponsors and Collaborators
Junle Liu
Investigators
Study Chair: Zhang Hong, Ph.D Professor and Director, Anesthesia and Operation Center, Chinese People's Liberation Army General Hospital
  More Information

Publications:
Responsible Party: Junle Liu, Principal Investigator, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT01782612     History of Changes
Other Study ID Numbers: THPPLA2013
First Submitted: January 28, 2013
First Posted: February 4, 2013
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by Junle Liu, Chinese PLA General Hospital:
Balanced Anesthesia
Nerve Block
Postoperative Recovery
Delirium
Postoperative Complications
Stress
Inflammation

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anesthetics
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents