Pain after low dose of spinal anaesthesia with local anaesthetic and morphine versus sufentanil used for broken hips

Intrathecal morphine versus sufentanil in ultra-low dose of isobaric bupivacaine in the management of postoperative pain in patients with hip fractures

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-003178-22-DK

Enrollment

142

Registered

2022-09-20

Start date

2022-11-16

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients Habile MedDRA version: 20.0 Level: LLT Classification code 10041537 Term: Spinal anaesthesia (all forms) System Organ Class: 100000004865

Interventions

Trade Name: Morphine 10mg/ml Pharmaceutical Form: Injection/infusion CAS Number: 57-27-2 Other descriptive name: Morphine Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA I-III, Weight: =65 years) yes F.1.3.1 Number of subjects for this age range 132

Exclusion criteria

Exclusion criteria: Patient refusal, local Infection at injection site, consumers of opioids, sedatives, or antidepressant, dementia, allergies to the medication, dys-coagulated patients, ASA IV-VI, weight: > 100 kg, height 185 cm, previous spinal surgery, dysmorphic vertebral column, HIP fracture re-operation, active peripheral nerve block, general anesthesia, MAO inhibitors and liver insufficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary outcome is the efficacy of spinal anesthesia, time for sufficient spinal block, time for first analgesic requirement and the amount of opioids used.;Secondary Objective: Is there a remarkable difference between the morphine- and the sufentanil group with respect to the secondary outcome: Respiratory depression, hypotension, pruritus, urination, nausea and/or vomiting;Primary end point(s): Pain VAS Score;Timepoint(s) of evaluation of this end point: 24 hours	—

Measure

Time frame

Main Objective: The primary outcome is the efficacy of spinal anesthesia, time for sufficient spinal block, time for first analgesic requirement and the amount of opioids used.;Secondary Objective: Is there a remarkable difference between the morphine- and the sufentanil group with respect to the secondary outcome: Respiratory depression, hypotension, pruritus, urination, nausea and/or vomiting;Primary end point(s): Pain VAS Score;Timepoint(s) of evaluation of this end point: 24 hours

—

Secondary

Measure	Time frame
Secondary end point(s): Respiratory depression, hypotension, pruritus, urination, nausea and/or vomiting;Timepoint(s) of evaluation of this end point: 24 hours	—

Countries

Denmark

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026