The efficacy of continuous-flow cryo and cyclic compression therapy after hip fracture surgery on postoperative pain: design of a prospective, open-label, parallel, multicenter, randomized controlled, clinical trial

Table 1 Criteria for participants in the trial

Inclusion criteria	Exclusion criteria
* Intra or extracapsular proximal femur fracture	* Fractures at multiple foci
* Intra or extracapsular proximal femur fracture	* Open fracture/wounds^a
* Aged 18 years and over	* Acetabular fracture
* Informed consent or proxy consent	* (Suspicion of) concomitant malignancy
	* BMI > 40
	* Unwilling to give proxy consent
	* Preoperative osteosynthesis materials in situ in the ipsilateral leg above knee level
	* Morphine allergy or dependence
	* ASA ≥ 4
	* Cryoglobulinemia
	* M. Raynaud
	* Central neuromuscular disorder
	* Absent ADP/ATP pulsations in the injured extremity
	* Active deep vein thrombosis
	* Suspected pulmonary embolism
	* Patient delay > 24 h
	* NYHA-class ≥ 3
	* IQ-CODE score ≥ 4.6*
	* Long-acting femoral blocks
	* Use of LIA
	* Postoperative HD-instability

^aOpen wounds unable to close per primam, * The IQ-CODE is only administered if the clinician has doubts about the cognitive status of the intented participant
BMI body mass index, ASA American Society of Anesthesiologists, ADP dorsal pedal artery, ATP posterior tibial artery, NYHA New York Heart Association, IQ-CODE Informant Questionnaire for the Cognitive Decline in the Elderly, LIA local infiltration anesthesia, HD hemodynamic

ISSN: 1471-2474