Effect of Tourniquet Abstention on Pain Reduction in Venous Sampling in the Elderly People (NO-GARROT)

Hôpital NOVO

Status: Completed

Conditions: Venous Puncture

Treatments: Procedure: Without tourniquet; Procedure: Fabric tourniquet; Procedure: Rubber tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT05226364

2021-A02936-35 (Other Identifier)

CHRD0319

Details and patient eligibility

About

This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

Full description

Almost 3 million people aged 70 and over are hospitalized once or more each year. The implementation of multiple treatments in these fragile patients, often poly-pathological requires a regular biological monitoring. For these patients, samples must be taken on average every two days.

This population often has a fragile venous capital due to reduced skin elasticity, undernutrition more or less associated with dehydration, the use of certain venous-toxic treatments and / or repetition of the gesture taking into account the monitoring biological closely related to long-term therapies.

With the aim of well-treatment and well-being, the reduction of patient pain is one of the major concerns of caregivers and in particular pain induced by treatment.

In children, the practice of harvesting without tourniquet is already frequent (18) and our preliminary study has confirmed us on the tourniquet as one of the acts responsible for the pain that the caregiver can possibly abstain.

No study had been conducted on this subject in the adult population and more particularly the elderly population. This prospective study evaluates the effect of abstaining from tourniquets on pain reduction during the venous puncture of the elderly people.

Enrollment: 240 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 75 years and over,
• Hospitalized in internal medicine or geriatric department,
• For which the 2 upper limbs are accessible to venous puncture (due to the multiple attempts that may be necessary to take a sample during the hospitalization),
• For which at least one vein is visible or palpable on an upper limb,
• Without venous puncture since admission in the department,
• Patient who did not receive a topical anesthetic before the venous puncture (Emla type)
• Communicating patient, able to assess their pain on a digital scale,
• Patients with affiliation to a social security system or beneficiary ,
• Written informed consent (IC) obtained.

Exclusion criteria

• Patient already included,
• Previous pain localized to the upper limbs,
• Hematoma at the planned site of skin-vascular breakage,
• Hemiplegic or quadriplegic patient,
• Patient with lymphedema in the upper limbs,
• Patient with behavioral disorders that may interfere with the proper functioning of the sampling,
• Patient with cognitive impairment preventing understanding of the study and adequate assessment pain (CODEX cognitive score of category C or D),
• Patient placed under legal protection (guardianship).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 3 patient groups

Rubber tourniquet

Experimental group

Description:

The blood sample is taken with a rubber tourniquet,

Treatment:

Procedure: Rubber tourniquet

Fabric tourniquet

Experimental group

Description:

The blood sample is taken with a a fabric tourniquet

Treatment:

Procedure: Fabric tourniquet

No tourniquet

Experimental group

Description:

The blood sample is taken without tourniquet

Treatment:

Procedure: Without tourniquet