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Clinical implemented specification of isobaric spinal anesthesia with fine needle puncture and combination of fentanyl and bupivacaine

Effects of bupivacaine combined with different opioids on short-term and long-term complications of lower extremity orthopaedic surgery in elderly patients: a multicenter, prospective, randomized, parallel-controlled study - Effects of bupivacaine combined with different opioids on short-term and long-term complications of lower extremity orthopaedic surgery in elderly patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058362
Enrollment
Unknown
Registered
2022-04-07
Start date
2022-04-06
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Postoperative adverse reaction

Interventions

1:bupivacaine 15mg + fentanyl 25 µ g
2:bupivacaine 15mg + fentanyl 50 µ g
3:bupivacaine 15mg + sufentanil 5 µ g
4:bupivacaine 15mg + sufentanil 10 µ g

Sponsors

Ning Xia People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Age = 60 and<90, regardless of gender or nationality; 2. ASA classification I-III; 3. Planned orthopedic operation of lower limbs; 4. Intraspinal anesthesia is planned; 5. Agree to participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a history of schizophrenia, epilepsy, Parkinson's disease or myasthenia gravis in the past; 2. Those who have blood coagulation dysfunction, history of spinal trauma, and lumbar lesions that are not easy to be anesthetized in the spinal canal or infected at the puncture site; 3. Those unable to communicate due to coma, severe dementia, language disorder, terminal disease, etc. before operation; 4. Critical condition (preoperative ASA grade = IV); Severe renal function damage (those who need renal replacement therapy); Severe liver function damage (Child Pugh grade C); Serious cardiac insufficiency (NYHA = Grade III); 5. If the treated doctor or researcher thinks that there are other circumstances that are not suitable for participating in this study, the reason shall be recorded.

Design outcomes

Primary

MeasureTime frame
Intraoperative adverse reactions;Short-term adverse reactions;Short-term neurological complications;Lumbago;Long-term neurological complications;—

Secondary

MeasureTime frame
Vital signs;Anesthetic effect and time;Intraoperative use of vasoactive drugs (type, dose);Operation condition;Stress response;Lower limb thrombosis;Pain assessment;Patient satisfaction;New arrhythmia or myocardial ischemia after operation;Pain assessment;Survival rate;—

Countries

China

Contacts

Public ContactQingshan Ye

People’s Hospital of Ningxia Hui Autonomous Region

yeqingshan@hotmail.com+86 13895381868

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026