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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Treatment groups

535 Participants
are divided into 5 treatment groups
Group A: intervention group 1Experimental treatment 1 intervention
Group B: intervention group 2Experimental treatment 1 intervention
Group C: intervention group 3Experimental treatment 1 intervention
Group D: intervention group 4Experimental treatment 1 intervention
Group E: control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

postoperative sufentanil consumption via PCA

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

Time frame
At 48 hours after the operation

Secondary outcomes

1

Cumulative consumption of sufentanil by PCA

Time frame
During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation
2

PCA pump first press time

Time frame
Within 48 hours after the operation.
3

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

0 indicates no pain, 10 indicates the most severe pain imaginable.

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

Intraoperative opioid dosage

Time frame
During the operation

Other outcomes

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