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The efficacy of intrathecal nalbuphine for postoperative pain control in lumbar spine surgery: A double-blind randomized control trial.

The efficacy of intrathecal nalbuphine for postoperative pain control in lumbar spine surgery: A double-blind randomized control trial.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241130002
Enrollment
80
Registered
2024-11-30
Start date
2025-02-01
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

patient undergoing lumbar spine surgery lumbar spine surgery

Interventions

no intrathecal injection,intrathecal nalbuphine 1 mg before wound closure
no intervention,intrathecal nalbuphine

Sponsors

Navamindradhiraj university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. patients undergoing lumbar spine surgery from the L2 level to the sacrum 2. Patients aged between 18-70 years 3. Patients with an American Society of Anesthesiologists (ASA) physical status of I-III

Exclusion criteria

Exclusion criteria: 1.Patients allergic to the study drug or its components 2.Patients with uncontrolled asthma 3.Patients with ischemic heart disease 4.Patients with elevated intracranial pressure 5.Patients with impaired liver or kidney function (glomerular filtration rate <30 ml/min) 6.Patients with abnormal blood coagulation 7.Patients with a history of gastrointestinal ulcers or bleeding 8.Patients with a history of continuous opioid use for 3 months or more, except in cases where opioids have been discontinued and are not for chronic pain conditions 9.Patients unable to assess pain levels 10.Pregnant or breastfeeding patients 11.Patients undergoing minimally invasive surgery 12.Patients who refuse to participate in the study

Design outcomes

Primary

MeasureTime frame
postoperative pain 48 hours after operation Numerical rating scale

Secondary

MeasureTime frame
morphine consumption 48 hours after operation patient-controlled analgesia (PCA) ,nausea vomiting 48 hours after operation Nausea and vomiting score ,sedation 48 hours after operation sedation score,respiratory depression 48 hours after operation respiratory rate

Countries

Thailand

Contacts

Public Contactwanutchaporn sujarittham

Faculty of medicine Vajira hospital, Navamindradhiraj university

wanutchaporn@nmu.ac.th0821644636

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026