Hip Fractures Clinical Trial
Official title:
Comparison of the Effects of Pericapsular Nerve Group (PENG), Suprainguinal Fascia Iliaca Compartment (S-FICB) and 3-1 Blocks on Comfort in Positioning for Unilateral Spinal Anesthesia and Postoperative Pain in Hip Fracture Surgery
Verified date | June 2023 |
Source | Bozyaka Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Hip fracture is a common cause of surgery, especially in elderly patients. Unilateral spinal anesthesia in hip fracture surgery can prevent the undesirable effects of spinal anesthesia due to sympathetic blockade. However, severe pain in hip fracture patients limits the positioning required for unilateral spinal anesthesia. The sedation and analgesia required to position patients with fractured hip remains inferior may cause respiratory depression, hemodynamic instability or postoperative cognitive impairment, especially in elderly patients. Lower extremity peripheral blocks can be used preoperatively to minimize the use of sedatives that may be required during positioning and to provide effective and safe analgesia.
Status | Active, not recruiting |
Enrollment | 90 |
Est. completion date | December 1, 2023 |
Est. primary completion date | November 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years and over - American Society of Anesthesiologists Physical Status Classification(ASA) I,II and III - Fully oriented and able to cooperate - Consented to participate in the study by signing the informed consent form - Patients with hip fracture and planned unilateral surgery with spinal anesthesia Exclusion Criteria: - Patients under 18 years of age - Refusal to participate - American Society of Anesthesiologists Physical Status Classification(ASA) IV-V - Non-cooperation - Coagulopathy or thrombocytopenia - Allergic to local anesthetics and analgesics - Patients with anatomical abnormalities or active infection at the points of application |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Bozyaka Training and Research Hospital | Izmir | Karabaglar |
Lead Sponsor | Collaborator |
---|---|
Bozyaka Training and Research Hospital |
Turkey,
Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation
Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24. — View Citation
Winnie AP, Ramamurthy S, Durrani Z. The inguinal paravascular technic of lumbar plexus anesthesia: the "3-in-1 block". Anesth Analg. 1973 Nov-Dec;52(6):989-96. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positional Pain in Unilateral Spinal Anesthesia | Pain in the pre-block period and during unilateral spinal anesthesia positioning after the block will be evaluated by VAS score. | 30 minutes after the block is performed | |
Secondary | Position Quality in Unilateral Spinal Anesthesia | The quality of the patient position will be assessed by Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed (0 = insufficient, 1 = sufficient, 2 = good, 3 = optimal) | 30 minutes after the block is performed | |
Secondary | The Necessity for Sedoanalgesia for Positional Pain in Unilateral Spinal Anesthesia | The necessity for sedoanalgesia for pain in the unilateral spinal anesthesia position will be assessed by the Anesthesiologist B who administers spinal anesthesia and is blind to the blocks performed. Rescue sedoanalgesia (propofol - ketamine combination) will be applied to patients with VAS >3. Patients will be recorded as 1 = needing sedoanalgesia, 2 = not needing sedoanalgesia. | 30 minutes after the block is performed | |
Secondary | Postoperative Pain | Postoperative pain at 2nd, 6th, 12th and 24th hours will be evaluated using VAS by Anesthesiologist B who is blind to the blocks performed. | Postoperative 2nd, 6th, 12th and 24th hours | |
Secondary | The Time Until First Opiod Requirement | Within the first 24-hour-period, as soon as the VAS >3, intravenous opiod (1 mg/kg Tramadol) will be administered and time to first opioid requirement will be recorded. | Postoperative first 24-hour-period | |
Secondary | Postoperative First 24-hour-period Total Opioid Consumption | Total opioid (tramadol) consumption in the first 24 hours postoperatively will be recorded in mg/kg/day. | Postoperative first 24-hour-period | |
Secondary | Patient and Surgeon Satisfaction | Patient and surgeon satisfaction will be evaluated as: 1 = Complete dissatisfaction, 2 = Moderate dissatisfaction, 3 = Moderate satisfaction, 4 = Complete satisfaction | Immediately after the surgery | |
Secondary | Undesirable Side Effects | Recorded when there is vascular puncture, hematoma, signs of LA toxicity. | Postoperative first 24-hour-period |
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