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Effectiveness of Perioperative Dexamethasone and Bupivacaine for Reducing Postoperative Pain in Posterior Lumbosacral Spine Surgery: A preliminary randomized double blind placebo-controlled trial

Effectiveness of Perioperative Dexamethasone and Bupivacaine for Reducing Postoperative Pain in Posterior Lumbosacral Spine Surgery: A preliminary randomized double blind placebo-controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20170807002
Enrollment
Unknown
Registered
2017-08-07
Start date
2015-08-03
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

Degenerative lumbar spine

Interventions

Before closure of the surgical wound&#44
the experimental group received an absorbable gelfoam soaked with a 1 ml (5 mg) of dexamethasone and 0.5% bupivacaine diluted to 2 ml placed on the epidural space. ,Before closure of the surgical woun
the placebo group received an absorbable gelfoam soaked with normal saline 2 ml placed on the epidural space.
Experimental Drug,Placebo Comparator Drug

Sponsors

Department of Orthopaedics Faculty of Medicine Chiang Mai University
Lead Sponsor
Department of Orthopaedics Faculty of Medicine Chiang Mai University
Collaborator

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.) Age ≥ 18 2.) ASA physical status I or II 3.) Can operate patient-controlled analgesia (PCA) device 4.) Degenerative condition of spinal disease 5.) No previous spinal surgery

Exclusion criteria

Exclusion criteria: 1.) Allergy to steroid or bupivacaine or morphine 2.) Prohibit to substance made from pig e.g. Muslim 3.) Pregnancy or lactating 4.) Infection, trauma or tumor spinal condition 5.) History previous spinal surgery 6.) Smoking

Design outcomes

Primary

MeasureTime frame
Comparison pain intensity in 48 hrs post-op by use Numeric rating scale 48 hr postoperation Pain scores (Use Numerical Rating Scale) were recorded postoperatively at 8, 16, 24 and 48 hr

Secondary

MeasureTime frame
Comparison Morphine consumption dose(mg) in 48 hrs post-op 48hr post operation Morphine consumption dose(mg) were recorded postoperatively at 8, 16, 24 and 48 hr,Incidence of surgical site infection in 1 month post-op and pseudathrosis at 6 month post-op 1 month post-op for surgical site infection and 6 month post-op for pseudarthrosis follow up patients at out patients clinic and observe for complication

Countries

Thailand

Contacts

Public ContactNattharut Chaibhuddanugul

Department of Orthopaedics faculty of Medicine Chiang Mai university

beth_na@hotmail.com0896442929

Outcome results

None listed

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