Hip Fracture Clinical Trial
Official title:
The Effects of Pericapsular Nerve Group (PENG) Block and Fascia Iliaca Plane Block on Preoperative and Postoperative Analgesia Before Spinal Anaesthesia in Patients Undergoing Hip Fracture Surgery
The aim of this study is to apply pericapsular nerve group (PENG) block or fascia iliaca plan block using ultrasonography to patients who will undergo hip fracture surgery, while giving sitting position before spinal anaesthesia and to reduce postoperative pain complaints. Thanks to these blocks, it is aimed to reduce pain complaints and the need for morphine-derived painkillers before and after surgery.
Status | Completed |
Enrollment | 67 |
Est. completion date | January 30, 2024 |
Est. primary completion date | January 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients between 18-70 years of age, - American Society of Anesthesiologists (ASA) Classification I-III, - scheduled for hip fracture surgery under spinal anaesthesia Exclusion Criteria: - American Society of Anesthesiologists (ASA) Classification >III - known allergy to local anaesthetics - presence of preoperative chronic pain - presence of coagulopathy - those who are unable to give written consent |
Country | Name | City | State |
---|---|---|---|
Turkey | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Diyarbakir |
Lead Sponsor | Collaborator |
---|---|
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital |
Turkey,
Choi YS, Park KK, Lee B, Nam WS, Kim DH. Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca Compartment Block for Total Hip Arthroplasty: A Randomized Clinical Trial. J Pers Med. 2022 Mar 6;12(3):408. doi: 10.3390/jpm12030408. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of pain level | Assessment of pain level with the Numerical Rating Scale (NRS) :
The 11-point numerical scale ranges from '0' representing one pain end (e.g. "no pain") to '10' representing the other pain end (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). |
1: measured in neutral position before the block. 2: measured with 15 degrees elevation of the affected limb before the block.3: Measured in spinal positioning. 4: Measured between 0-2 hours postoperatively. 5: Measured between 2-8 hours postoperatively | |
Primary | Evaluation of ease of positioning | It was determined by means of a scale scored from 0-3 (0=no positioning, 1=standing in abnormal posture due to pain and needing support for positioning 2=mild discomfort but no need for support for positioning 3=able to position on their own without pain). | Procedure (at the stage of introduction of spinal anaesthesia) | |
Secondary | Agitation assessment | Agitation assessment with Richmond Agitation Sedation Scale (RASS) is a 10-point scale ranging from -5 to +4.Levels -1 to -5 denote 5 levels of sedation, starting with "awakens to voice" and ending with "unarousable." Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS level 0 is "alert and calm. | During positioning for spinal anaesthesia procedure | |
Secondary | mean blood pressure | Mean blood pressure assessed using automatic sphygmomanometer over a 60 second interval | Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure) | |
Secondary | Heart rate | The number of heart beats per minute obtained by electrocardiographic monitoring | Intraoperative (1- Baseline 2- During spinal block 3- 5th minutes after spinal block 4- Every 10 minutes during the operation 5- Skin closure) | |
Secondary | Tramadol consumption after surgery | Total amount of tramadol consumed within 24 hours after surgery | 24 hours postoperatively | |
Secondary | Time of first analgesia use | Duration of the first analgesic requirement after surgery (in hours) | up to 24 hours (Duration of the first analgesic requirement after surgery (in hours)) | |
Secondary | Limb range of motion | Limb range of motion assessed using goniometer | 1- Postoperative 4th hours , 2- Postoperative 8th hours | |
Secondary | Patient satisfaction score | Patients' satisfaction with the quality of pain management will be assessed on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = quite unsatisfied; 3 = moderate; 4 = quite satisfactory; 5 = very satisfactory. | Second postoperative day | |
Secondary | Number of Participants with Side effects | Number of Participants with side effects such as neurological deficit, oedema, haematoma, nausea and vomiting will be evaluated by physical examination, patient anamnesis and nurse follow-up forms | within 24 hours postoperatively |
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