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Comparison of the effect of preoperative continue femoral nerve block and paracetamol administration on preoperative pain management and postoperative delirium incidence of geriatric patients

Comparison of the effect of preoperative continue femoral nerve block and paracetamol administration on preoperative pain management and postoperative delirium incidence of geriatric patients scheduled for trochanteric femur fracture

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000546257
Acronym
FNBT (Femoral Nerve Block Trial)
Enrollment
91
Registered
2018-04-12
Start date
2018-04-15
Completion date
2018-08-14
Last updated
2019-01-14

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

Conditions

None listed

Brief summary

Our primary aim in this study is to evaluate the effect of early pain management after hip fracture with either continuous femoral nerve block or paracetamol infusion on postoperative delirium incidence. Our secondary aim is to determine the relation between postoperative delirium incidence and interleukin 6 and interleukin 8 levels in cerebrospinal fluid.

Interventions

Patients who are older than 65 years old and applied to emergency service with hip fracture diagnosis will be included in the study. All of the patients will be assessed for the presence of delirium with 16 items Delirium Rating Scale-Revised Version (DRS-R-98). The patients with preoperative delirium will be excluded from the study. The participants will receive 2 lt/minute oxygen supplementation and standard nutritional support. Preoperative hemoglobin level will be raised to 10 g/dl in all of

Patients who are older than 65 years old and applied to emergency service with hip fracture diagnosis will be included in the study. All of the patients will be assessed for the presence of delirium with 16 items Delirium Rating Scale-Revised Version (DRS-R-98). The patients with preoperative delirium will be excluded from the study. The participants will receive 2 lt/minute oxygen supplementation and standard nutritional support. Preoperative hemoglobin level will be raised to 10 g/dl in all of the patients prior to the surgery. Then the patients will randomly be divided into two groups; in the first group, patients will receive 5 mg/kg paracetamol intraveously at every 8 hours until the operation day (maximum 48 hours). In the second group, a femoral nerve block will be done with the guidance of ultrasonography and a catheter will be inserted, then 0.5 ml/kg bupivacaine %0.25 will be administered through the femoral nerve catheter until the operation day (maximum 48 hours). The pain levels of the patients will be assessed using a 100mm visual analog scale four hours after the paracetamol administration in the first group and femoral block in the second group. If needed, intravenous tramadol 0.5 mg/kg will be applied as rescue analgesic in both of the groups. In the operating room, all of the patients will receive a spinal-epidural combined anesthesia as anesthetic management. The pain occurred related to positioning for regional anesthesia will be recorded using a 100mm visual analogue scale. During the dural puncture, 2 ml of cerebrospinal fluid will be taken for analysis of interleukin 6 and interleukin 8 levels with enzyme linked immunoassay. For spinal anesthesia, 10 mg bupivacaine and 20 mcg fentanyl will be applied intrathecaly. The postoperative analgesia will be managed with 5 ml/hour of bupivacaine 0.125% and 100 mcg fentanyl through the epidural catheter in all the patients. The patients will be assessed with DRS-R-98 for presence of delirium at postoperative first, second and third days.

Sponsors

Ali Ihsan UYSAL
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age over 65, ASA status II-IV, diagnosis of hip fracture

Exclusion criteria

Presence of preoperative delirium, hip fracture related to malignancy, known allergy to paracetamol and bupivacaine, parkinson's disease, presence of a contraindication for regional anesthesia, epilepsy, cholinesterase inhibitor use

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026