Comparison of Two Kinds of Postoperative Analgesia After Amputation

• ClinicalTrials.gov Identifier: NCT02114463
• Recruitment Status: Unknown
• First Posted: April 15, 2014
• Last Update Posted: March 12, 2015
• Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Information provided by (Responsible Party): bo xu, Guangzhou General Hospital of Guangzhou Military Command

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Complications	Procedure: Local analgesic; Procedure: Intravenous analgesic; Drug: ropivacaine; Drug: flurbiprofen	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial
• Study Start Date: March 2014
• Estimated Primary Completion Date: August 2016
• Estimated Study Completion Date: August 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Local analgesic; This group uses local analgesia infusion pump of 0.2% ropivacaine 360ml through periarticular infiltration for postoperative analgesia.	Procedure: Local analgesic; Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.; Drug: ropivacaine; 0.2% ropivacaine
Active Comparator: Intravenous analgesic; This group is treated with intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg.	Procedure: Intravenous analgesic; People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.; Drug: flurbiprofen; flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg

Outcome Measures

Primary Outcome Measures :

1. pain [ Time Frame: 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 :

1. Phantom pain [ Time Frame: three months postoperation ]
   Investigators asked the patient wether there is phantom pain at three months after surgery
2. complication [ Time Frame: 72 hours postoperation ]
   Investigators document the incidence of nausea,vomiting,headache,urinary retention and et al

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Contacts

Contact: bo xu, associate chief physician; 88653387 ext 020; xubo333@hotmail.com

Locations

China, Guangdong

Guangzhou Military Region General Hospital, Department of Anesthesiology; Recruiting

Guangzhou, Guangdong, China, 510010

Contact: Dong Xu Zhou 13268260337 ext 86 13268260337@163.com

Sponsors and Collaborators

Guangzhou General Hospital of Guangzhou Military Command

More Information

• Responsible Party: bo xu, associate chief physician, Guangzhou General Hospital of Guangzhou Military Command
• ClinicalTrials.gov Identifier: NCT02114463
• Other Study ID Numbers: Phantom limb pain
• First Posted: April 15, 2014
• Last Update Posted: March 12, 2015
• Last Verified: March 2015

Keywords provided by bo xu, Guangzhou General Hospital of Guangzhou Military Command:

Local analgesia system; Ropivacaine; Analgesic efficacy after operation; Postoperative

Additional relevant MeSH terms:

Flurbiprofen; Flurbiprofen axetil; Pentazocine; Dezocine; Palonosetron; Ropivacaine; Analgesics; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia