Comparison of Two Kinds of Postoperative Analgesia After Amputation

Phase 4

• Conditions: Complications; Pain
• Interventions: Procedure: Intravenous analgesic; Procedure: Local analgesic; Drug: ropivacaine; Drug: flurbiprofen

• Registration Number: NCT02114463
• Lead Sponsor: Guangzhou General Hospital of Guangzhou Military Command

Brief Summary

Pain after amputation is a significant problem among amputees. Phantom limb pain may appear in up to 85% of patients and is usually resistant to a wide variety of treatments.It is believed that regional anesthesia, by preventing the establishment of central sensitization, may play a role in reducing the incidence of acute and chronic pain. Therefore the investigators will compare two methods of postoperative analgesic after after amputation by their efficiency and complication.

Detailed Description

Peripheral nerve transection results in an afferent nociceptive barrage that initiates spinal cord hyperexcitability with expansion of the receptive fields of dorsal horn neurons that respond to the nearest intact afferents. These neuroplastic changes are believed to be responsible for the development of postsurgical chronic pain syndromes, including phantom limb and stump pain.At present, there are no randomized studies with sample sizes that ensure power, or blinded for end-point assessment,to support the evidence on pharmacological and non-pharmacological treatments of Pain after amputation. Consequently, our study was designed to arrive at clear conclusions about treatment efficacy and to give stronger recommendations for clinical practice.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-12
• Study First Posted: 2014-04-15
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients of American Association of anesthetists（ASA）Grade 1 or 2
2. Aged between 18 and 65 years
3. Undergoing elective total knee replacement

Exclusion Criteria

1. Mental illness can not match
2. Nerve block, epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. History of chronic headaches and long-term use of analgesic drugs
5. People who were postoperative consciousness, language or hearing impaired

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous analgesic	Intravenous analgesic	This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.
Local analgesic	Local analgesic	This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
Local analgesic	ropivacaine	This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.
Intravenous analgesic	flurbiprofen	This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.

Primary Outcome Measures

Name	Time	Method
pain	72 hours postoperation	Up to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.

Secondary Outcome Measures

Name	Time	Method
Phantom pain	three months postoperation	Investigators asked the patient wether there is phantom pain at three months after surgery
complication	72 hours postoperation	Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al

Trial Locations

Locations (1)

Guangzhou Military Region General Hospital, Department of Anesthesiology; 🇨🇳 Guangzhou, Guangdong, China