Trials / Completed
CompletedNCT03319563
Kyphoscoliosis Surgery: Blood Conservation and Analgesia
High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Mansoura University · Academic / Other
- Sex
- All
- Age
- 8 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
Since the first spinal fusion by Hibbs 1911, yet anesthesia for correction of scoliosis is challenging due to frequently associated co-morbidities, the extensive nature of surgery and liability for many complications. Among the major concerns for anesthesiologists are the pain and bleeding. Scoliosis correction accounts for massive blood loss that may exceed more than half of blood volume. There are many strategies for blood conservation; however sometimes some of them may not be suitable. For analgesia, the most frequently loco regional analgesic techniques in spine surgery are intrathecal, epidural or local infiltration techniques. infiltration data reviled inconclusive and heterogeneous results. Our purpose is to optimize blood conservation and analgesia through anatomically based modification of the infiltration technique.
Detailed description
The most frequently loco-regional analgesic techniques in scoliosis surgery are intrathecal, epidural, caudal morphine, or local infiltrations techniques including ultrasound guided thoracolumbar interfascial plane block. however these techniques possess some limitations in scoliosis surgery. Local anesthetic infiltration was first applied over 35 years ago in lumbar spine surgery as a reliable technique for pain relief. However meta-analysis of data reviled inconclusive and heterogeneous efficacy results.This conflict arise from the differences in the technique and drugs.There are three levels of infiltration; subcutaneous, muscular and perineural. Its timing either pre-incision or post-surgery. Generally the preemptive and deep infiltration offer better analgesia when compared with post-surgical and superficial forms. Different drugs including local anesthetics, epinephrine and adjuvants can be given as a single injection or infusion. Doses and volumes are also different, usually ranging from 10 to 30 ml at a concentration of 0.25% Bupivacaine. the use of epinephrine helps bleeding control Concomitantly, unlike the other techniques, bupivacaine infiltration was combined at three levels in this study; subcutaneous, muscular and neural paravertebral to provide sensory, motor and sympathetic blockade all together. In addition, this drug combination may help to maintain spinal cord perfusion by avoiding deliberate hypotension. The high volume sufficient for proper tissue infiltration combined at three anatomically guided levels for three types of nerves has not been described so far. This research may benefit all spine surgery patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Local anesthetic-epinephrine | * Bupivacaine 0.5% (Astra Zeneca) 2 mg/Kg. * Lidocaine 5 mg/Kg. * Epinephrine 5 mcg/ml of the total volume. * Add normal saline to a total volume of 100 ml/10 cm of the wound length. |
| DRUG | Saline | normal saline 100 ml/10 cm of the wound length |
Timeline
- Start date
- 2017-04-11
- Primary completion
- 2017-10-10
- Completion
- 2017-10-10
- First posted
- 2017-10-24
- Last updated
- 2020-10-26
Locations
1 site across 1 country: Egypt
Source: ClinicalTrials.gov record NCT03319563. Inclusion in this directory is not an endorsement.