Minimum Effective Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery

NCT06785350 | Recruiting DMC

• 1 other identifier: KY2024-365-02-1
• Study Type: interventional
• Target: 535
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain Management; Spine Surgery

Outcome Measures

Primary Outcomes (1)

• postoperative sufentanil consumption via PCA

  The cumulative 48 hours postoperative sufentanil consumption via PCA was the primary outcome of our study

  At 48 hours after the operation

Secondary Outcomes (13)

• Cumulative consumption of sufentanil by PCA

  During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation

• PCA pump first press time

  Within 48 hours after the operation.

• VAS score at during movement (VASm) and at rest (VASr)

  At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively

• Intraoperative opioid dosage

  During the operation

• Time to first analgesic remediation

  Until 3 months after surgery

Study Arms (5)

intervention group 1

EXPERIMENTAL

0.012%diprospan+0.5%ropivacaine

Drug: 0.012%diprospan+0.5%ropivacaine

intervention group 2

EXPERIMENTAL

0.009%diprospan+0.5%ropivacaine

Drug: 0.009%diprospan+0.5%ropivacaine

intervention group 3

EXPERIMENTAL

0.006%diprospan+0.5%ropivacaine

Drug: 0.006%diprospan+0.5ropivacaine

intervention group 4

EXPERIMENTAL

0.003%diprospan+0.5%ropivacaine

Drug: 0.003%diprospan+0.5%ropivacaine

control group

ACTIVE COMPARATOR

0.5%ropivacaine

Drug: 0.5%ropivacaine

Interventions

0.012%diprospan+0.5%ropivacaine DRUG

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 diprospan at concentrations of 0.012%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.

intervention group 1

0.009%diprospan+0.5%ropivacaine DRUG

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 diprospan at concentrations of 0.009%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.

intervention group 2

0.006%diprospan+0.5ropivacaine DRUG

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 diprospan at concentrations of 0.006%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.

intervention group 3

0.003%diprospan+0.5%ropivacaine DRUG

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 diprospan at concentrations of 0.003%, respectively. The surgeon will use a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.

intervention group 4

0.5%ropivacaine DRUG

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 a 22 G straight needle for local infiltration anesthesia near the planned incisions. Postoperatively, patients will receive tropisetron and a PCA pump delivering sufentanil and ondansetron. PCA usage (effective/ineffective presses) and supplemental analgesia with Tylenol or loxoprofen will be monitored for 48 hours and up to 3 months. Dosages and intraoperative parameters will be closely recorded throughout.

control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: January 4, 2025
• First Posted: January 21, 2025
• Study Start: January 25, 2025
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)