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Comparison of Two Kinds of Postoperative Analgesia After Amputation

Comparison of Two Kinds of Postoperative Analgesia After Amputation:a Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02114463
Enrollment
36
Registered
2014-04-15
Start date
2014-03-31
Completion date
2016-08-31
Last updated
2015-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications, Pain

Keywords

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

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.

Interventions

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.

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.

DRUGropivacaine

0.2% ropivacaine

DRUGflurbiprofen

flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg

Sponsors

Guangzhou General Hospital of Guangzhou Military Command
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
pain72 hours postoperationUp to 72 hours after operation,postoperative pain visual analogue scale(VAS) scores are used to evaluate the level of pain.

Secondary

MeasureTime frameDescription
Phantom painthree months postoperationInvestigators asked the patient wether there is phantom pain at three months after surgery
complication72 hours postoperationInvestigators document the incidence of nausea,vomiting,headache,urinary retention and et al

Countries

China

Contacts

Primary Contactbo xu, associate chief physician
xubo333@hotmail.com88653387

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026