PENG block and pre-habilitation

JRCT ID: jRCT1031220294

Registered date:26/08/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Femoral neck fracture
• Date of first enrollment: 02/11/2022
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Pericapsular Nerve Group Block using 20ml of 0.375% ropivacaine in intervention group; 20ml of saline in control group

Outcome(s)

• Primary Outcome: Success rate of mobilization in the initial preoperative rehabilitation (defined as transferring to a wheelchair with the assistance of a physical therapist)

Secondary Outcome

(1) Achievement of the following rehabilitation items in the initial rehabilitation (total of 5 items; 1 point if achieved, 0 point if not achieved, full score of 5 points; under the assistance of a physical therapist):
1) Bed sitting position
2) Edge sitting position
3) Stand up
4) Maintaining a standing position (holding a standing position for 10 seconds with support for unloading the affected leg using a walker)
5) Wheelchair transfer
(2) NRS (pain score) at the time of implementation of each item
(3) Level of achievement of rehabilitation after the second preoperative session
(4) Preoperative hemoglobin
(5) Intraoperative blood loss amount
(6) Complications within 1 week after surgery (thromboembolic event)
(7) POD3 Cumulated Ambulation Score (CAS; score that predicts postoperative patient's motor function; correlates with postoperative outcome)
(8) Achievement of postoperative rehabilitation using the protocol shown in (1)
(9) Required number of days for each postoperative rehabilitation item
(10) Discharge time
(11) Discharge destination (home, rehabilitation hospital, facility, unable to transfer hospital, etc.)
(12) Half year mortality, ADL

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients who are 20 years old or older at the time of obtaining the consent form
(2) Patients with a Garden stage 3-4 femoral neck fracture who are scheduled artificial head replacement surgery
(3) ASA-PS (American Society of Anesthesiologists physical status): 1 (good general condition without complications) to 3 (severe systemic disease but not incapacitated)

Exclude criteria

(1) Patients with dementia (defined as <3 points in Mini-cog test)
(2) Patients with allergies to the investigated drug
(3) Patients who could not mobilize before the injury (defined as leaving the bed)
(4) Patients with a history of ipsilateral artificial head replacement
(5) Patients with infection at the site where PENG block will be performed
(6) Patients who have pathological fracture
(7) Patients who are judged by the doctor in charge to be inappropriate for participation in this study

Related Information

• Primary Sponsor: Sugiyama Daisuke
• Source(s) of Monetary Support: the Department of Anesthesiology, Kameda Medical Center