Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 0.012%diprospan+0.5%ropivacaine, 0.009%diprospan+0.5%ropivacaine, 0.006%diprospan+0.5ropivacaine, 0.003%diprospan+0.5%ropivacaine.
- Who it may be relevant to
- Registry conditions: Pain Management, Spine Surgery. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial
Overview
Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.
Interventions
- Drug 0.012%diprospan+0.5%ropivacaine
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.5ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipros - Drug 0.009%diprospan+0.5%ropivacaine
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.375ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipr - Drug 0.006%diprospan+0.5ropivacaine
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.25ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipro - Drug 0.003%diprospan+0.5%ropivacaine
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 0.125ml of diprospan will be diluted to 30 ml with 15 ml of ropivacaine in 0.9% NaCl to prepare dipr - Drug 0.5%ropivacaine
At the preoperative visit, patients will sign informed consent and learn to use the patient-controlled analgesia (PCA) pump and assess pain with the visual analogue scale (VAS). Standard general anesthesia will be induced and maintained with sufentanil, propofol, cisatracurium or rocuronium, and sevoflurane. Before incision, neurosurgeons will administer the allocated local infiltration solution. 15 ml of ropivacaine will be diluted to 30 ml with in 0.9% NaCl, respectively. The surgeon will use
Primary outcome measures
- postoperative sufentanil consumption via PCA [Time frame: At 48 hours after the operation]
Secondary outcome measures (12)
- Cumulative consumption of sufentanil by PCA [Time frame: During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation]
- PCA pump first press time [Time frame: Within 48 hours after the operation.]
- VAS score at during movement (VASm) and at rest (VASr) [Time frame: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively]
- Intraoperative opioid dosage [Time frame: During the operation]
- Time to first analgesic remediation [Time frame: Until 3 months after surgery]
- Amount of postoperative oral analgesic remediation [Time frame: Until 3 months after surgery]
- Postoperative nausea and vomiting (POVN) [Time frame: At 2hours, 4hours, 8hours, 24hours, and 48hours postoperatively]
- Ramsay sedation score (RSS) [Time frame: At 2hours, 4hours, 8hours, 24hours, 48hours postoperatively]
- Satisfaction score [Time frame: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively]
- The World Health Organization Quality of Life (WHOQOL) [Time frame: At 3months postoperatively]
- Oswestry disability index (ODI) [Time frame: At 3months postoperatively]
- Patient and Observer Scar Assessment Scale (POSAS) [Time frame: At 3months postoperatively]
Eligibility criteria
Inclusion criteria
Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).
Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.
Exclusion criteria
Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI<15kg/m2 or>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score < 15 before surgery. Unable to provide written informed consent.
Withdrawal criteria:
Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.
Reoperation during follow-up.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- Beijing Tiantan Hospital — Beijing
Publications
- Wang Y, Han B, Zhao C, Ren H, Jia W, Luo F. Minimum effective dose of betamethasone for incisional local infiltration for the prevention of postoperative pain after spine surgery: study protocol for a randomised controlled trial. BMJ Open. 2025 Sep 28;15(9):e100725. doi: 10.1136/bmjopen-2025-100725. PMID 41022457
Identifiers
NCT: NCT06785350 · KY2024-365-02-1