Pain control with spinal morphine combined with spinal anesthesia before orthopedic surgery

Multimodal analgesia using 100 µg of preemptive intrathecal morphine sulfate combined with hyperbaric bupivacaine for postoperative pain control in orthopedic surgery: a double blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10993984

Enrollment

Registered

2018-05-16

Start date

2014-04-01

Completion date

Unknown

Last updated

2019-05-13

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

Conditions

Pain control Musculoskeletal Diseases Pain control

Interventions

Participants are randomly allocated to the experimental group or control. Those in the experimental group (M1) receive 100 µg of intrathecal morphine sulfate combined with 1-2 mL of hyperbaric bupivac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 years and older 2. ASA I and II 3. Lower limb fracture 4. Elective orthopedic surgery 5. Spinal anesthesia

Exclusion criteria

Exclusion criteria: 1. II 3. Documented allergy to opioids or non opioid analgesics 4. Emergency surgery 5. BMI >35 6. Asthma 7. Obstructive sleep apnea 8. Chronic use of opioids defined as more than > 2 weeks 9. Pregnancy 10. History of drug abuse or alcohol use 11. History of psychiatric condition

Design outcomes

Primary

Measure	Time frame
Pain is assessed by the following: 1.1. Individual interviews before discharge from the Post-Anesthesia Care Unit (baseline) and every single episode of pain during the first 24 hour post-operative period 1.2. Time to appearance of first episode of pain in the 24 hour post-operative period 1.3. Intensity of pain was measured using the verbal numeric rating scale (VNRS) 1.4. Frequency of pain episodes is measured throughout the 24 hour post-operative period	—

Measure

Time frame

Pain is assessed by the following: 1.1. Individual interviews before discharge from the Post-Anesthesia Care Unit (baseline) and every single episode of pain during the first 24 hour post-operative period 1.2. Time to appearance of first episode of pain in the 24 hour post-operative period 1.3. Intensity of pain was measured using the verbal numeric rating scale (VNRS) 1.4. Frequency of pain episodes is measured throughout the 24 hour post-operative period

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Secondary

Measure	Time frame
1. Type and quantity of analgesics needed is measured according the WHO's analgesic ladder throughout the 24 hour post operative period 2. Frequency of episodes of pruritus, nausea and vomiting, respiratory depression, and urinary retention are measured throughout the 24 hour post operative period 3. Patient satisfaction is evaluated using using a questionnaire based on the Likert scale in the first 24 hours	—

Measure

Time frame

1. Type and quantity of analgesics needed is measured according the WHO's analgesic ladder throughout the 24 hour post operative period 2. Frequency of episodes of pruritus, nausea and vomiting, respiratory depression, and urinary retention are measured throughout the 24 hour post operative period 3. Patient satisfaction is evaluated using using a questionnaire based on the Likert scale in the first 24 hours

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Countries

El Salvador

Outcome results

None listed

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