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Spinal Anesthesia versus Local Anesthesia with Sedation for Percutaneous Endoscopic Lumbar Discectomy-a Multicenter, Prospective, Randomized Trial (the SALAS trial)

Spinal Anesthesia versus Local Anesthesia with Sedation for Percutaneous Endoscopic Lumbar Discectomy-a Multicenter, Prospective, Randomized Trial (the SALAS trial)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080163
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-01-31
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Lumbar Disc Herniation

Interventions

Spinal Anesthesia (SA) Group:Subarachnoid injection of 7.5 mg ropivacaine (0.125% 6 ml)
Local Anesthesia with Sedation (LAS) Group:Surgical area local anesthesia+target oriented personalized dosing regimen of dexmedetomidine

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) PELD surgery with transforaminal approach for single-level lumbar disc herniation; 2) Age 18 years and above; 3) ASA = 3 points;

Exclusion criteria

Exclusion criteria: 1) PELD surgery with interlaminar approach; 2) allergies to anesthetic and sedative drugs; 3) spinal anesthesia is expected to be infected at the puncture site; 4) Abnormal coagulation function, long-term use of anticoagulant drugs without discontinuation; 5) Obvious calcification of intervertebral disc, obvious lumbar deformity, lumbar spinal stenosis, lumbar spondylolisthesis, lumbar spondylolysis, lumbar spine infection, lumbar tuberculosis, lumbar tumor, history of previous lumbar spine surgery; 6) history of analgesic drug abuse (Misuse of prescription pain relievers); 7) Hepatic and renal insufficiency; 8) Those who are trying to get pregnant, pregnant or breastfeeding; 9) Mentally ill patients and vulnerable groups.

Design outcomes

Primary

MeasureTime frame
Intraoperative back pain intensity (VAS);

Secondary

MeasureTime frame
Intraoperative VAS score for back and leg pain at multiple time points;Intraoperative analgesics use;Postoperative VAS score for back and leg pain at multiple time points;Postoperative analgesics use;Life of qualitu outcomes;

Countries

China

Contacts

Public ContactSun Haolin

Peking University First Hospital

sunhaolin@vip.163.com+86 136 8114 6159

Outcome results

None listed

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