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Safety and efficacy of cocktail analgesic injection during lumbar spinal fusion surgery

Safety and efficacy of cocktail analgesic injection during lumbar spinal fusion surgery: A prospective randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17013094
Enrollment
Unknown
Registered
2017-10-24
Start date
2017-12-01
Completion date
Unknown
Last updated
2017-11-06

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

Conditions

lumbar spinal stenosis or lumbar disc herniation

Interventions

Cocktail Group:cocktail analgesic injection and postoperative intravenous patient-controlled analgesia
Control Group:normal saline injection and postoperative intravenous patient-controlled analgesia

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged between 18 and 70 years; 2) On the surgical waiting list for primary lumbar spinal fusion surgery at PUMCH; 3) Diagnosed with lumbar spinal stenosis or lumbar disc herniation; 4) American Society of Anesthesiologists (ASA) physical status I~II; 5) Understand and comply with the study protocol.;Inclusion criteria: 1) Aged between 18 and 70 years; 2) On the surgical waiting list for primary lumbar spinal fusion surgery at PUMCH; 3) Diagnosed with lumbar spinal stenosis or lumbar disc herniation; 4) American Society of Anesthesiologists (ASA) physical status I~II; 5) Understand and comply with the study protocol.;Inclusion criteria: 1) Aged between 18 and 70 years; 2) On the surgical waiting list for primary lumbar spinal fusion surgery at PUMCH; 3) Diagnosed with lumbar spinal stenosis or lumbar disc herniation; 4) American Society of Anesthesiologists (ASA) physical status I~II; 5) Understand and comply with the study protocol.;Inclusion criteria: 1) Aged between 18 and 70 years; 2) On the surgical waiting list for primary lumbar spinal fusion surgery at PUMCH; 3) Diagnosed with lumbar spinal stenosis or lumbar disc herniation; 4) American Society of Anesthesiologists (ASA) physical status I~II; 5) Understand and comply with the study protocol.;Inclusion criteria: 1) Aged between 18 and 70 years; 2) On the surgical waiting list for primary lumbar spinal fusion surgery at PUMCH; 3) Diagnosed with lumbar spinal stenosis or lumbar disc herniation; 4) American Society of Anesthesiologists (ASA) physical status I~II; 5) Understand and comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity to parecoxib, ropivacaine, diprospan, fentanyl or sulfonamide; 2) Serious allergic reaction to any other drugs; 3) Gastrointestinal hemorrhage or ulcer; 4) Severe hepatic, renal, or cardiovascular dysfunction; 5) Perioperative period of coronary artery bypass surgery; 6) Pregnant, lactating or probably pregnant; 7) Revision surgery or surgery for neoplastic disease; 8) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); 9) Drug or alcohol abuse; 10) Limited Chinese language fluency.;Exclusion criteria: 1) History of hypersensitivity to parecoxib, ropivacaine, diprospan, fentanyl or sulfonamide; 2) Serious allergic reaction to any other drugs; 3) Gastrointestinal hemorrhage or ulcer; 4) Severe hepatic, renal, or cardiovascular dysfunction; 5) Perioperative period of coronary artery bypass surgery; 6) Pregnant, lactating or probably pregnant; 7) Revision surgery or surgery for neoplastic disease; 8) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); 9) Drug or alcohol abuse; 10) Limited Chinese language fluency.;Exclusion criteria: 1) History of hypersensitivity to parecoxib, ropivacaine, diprospan, fentanyl or sulfonamide; 2) Serious allergic reaction to any other drugs; 3) Gastrointestinal hemorrhage or ulcer; 4) Severe hepatic, renal, or cardiovascular dysfunction; 5) Perioperative period of coronary artery bypass surgery; 6) Pregnant, lactating or probably pregnant; 7) Revision surgery or surgery for neoplastic disease; 8) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); 9) Drug or alcohol abuse; 10) Limited Chinese language fluency.;Exclusion criteria: 1) History of hypersensitivity to parecoxib, ropivacaine, diprospan, fentanyl or sulfonamide; 2) Serious allergic reaction to any other drugs; 3) Gastrointestinal hemorrhage or ulcer; 4) Severe hepatic, renal, or cardiovascular dysfunction; 5) Perioperative period of coronary artery bypass surgery; 6) Pregnant, lactating or probably pregnant; 7) Revision surgery or surgery for neoplastic disease; 8) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); 9) Drug or alcohol abuse; 10) Limited Chinese language fluency.;Exclusion criteria: 1) History of hypersensitivity to parecoxib, ropivacaine, diprospan, fentanyl or sulfonamide; 2) Serious allergic reaction to any other drugs; 3) Gastrointestinal hemorrhage or ulcer; 4) Severe hepatic, renal, or cardiovascular dysfunction; 5) Perioperative period of coronary artery bypass surgery; 6) Pregnant, lactating or probably pregnant; 7) Revision surgery or surgery for neoplastic disease; 8) Inability to provide informed consent due to mental incompetence (e.g., intellectual disability, dementia); 9) Drug or alcohol abuse; 10) Limited Chinese language fluency.

Design outcomes

Primary

MeasureTime frame
Visual analogue scale;

Secondary

MeasureTime frame
Sufentanil consumption;Time to first use of IV-PCA;Rescue analgesia consumption;

Countries

China

Contacts

Public ContactShugang Li;Shugang Li;Shugang Li;Shugang Li;Shugang Li ;;;;

Peking Union Medical College Hospital;Peking Union Medical College Hospital;Peking Union Medical College Hospital;Peking Union Medical College Hospital;Peking Union Medical College Hospital

lishugangpumch@163.com;lishugangpumch@163.com;lishugangpumch@163.com;lishugangpumch@163.com;lishugangpumch@163.com+86 13051159880;+86 13051159880;+86 13051159880;+86 13051159880;+86 13051159880

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026