Posterior Spine SurgeryNCT03319563
Kyphoscoliosis Surgery: Blood Conservation and Analgesia
A study testing Local anesthetic-epinephrine and Saline in people with Posterior Spine Surgery, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Posterior Spine Surgery
- What is being tested?
- Local anesthetic-epinephrine and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2017to 10 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Kyphoscoliosis patients subjected for spinal correction.
- Age 8-18 years.
- American Society of Anesthesiologists I-II status.
Who cannot join
- Patient or parents refusal.
- Infection at surgical site.
- Hypersensitivity to amide local anesthetics.
- Coagulopathy.
- Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
- Sever cardiac, respiratory, renal or hepatic impairment.
- Presence of communication barrier.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital and Delta Hospital
Al Mansurah, Dakahlya, 35516
About this study
Official title: High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
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.
Read the 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
- Posterior Spine Surgery
- Being tested
- Local anesthetic-epinephrine, Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local anesthetic-epinephrineDrug
Also called infiltration group
- 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.
SalineDrug
Also called control group
normal saline 100 ml/10 cm of the wound length
| Study group | Role | What they receive |
|---|---|---|
| local anesthetic-epinephrine group | Experimental | after general anesthesia, the Infiltration cocktail was done by the surgeon at three levels:
1. Subcutaneous: before incision at a volume 20 ml/10 cm/side.
2. Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume.
3. Neural paravertebral: after exposure of the transverse processes. A volume of 5 ml/per each process of the same cocktail, 1 cm deep to the surface of the corresponding process before pedicular screws fixation after negative blood aspiration. Receives: Drug: Local anesthetic-epinephrine |
| saline group | Placebo comparator | after general anesthesia, the same infiltration volume and technique using normal saline. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss
milliliter
Measured: Intraoperative
Total Morphine consumption.
milligram
Measured: during first 24 hours postoperatively.
Secondary outcomes (26)
The surgical field visualization for subcutaneous incision
measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,
Measured: Intraoperative, 10 minutes after skin incision.
The surgical field visualization for muscular dissection
measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,
Measured: Intraoperative, 30 minutes after the thoracolumbar fascia incision,
The surgical field visualization for nails insertion
measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,
Measured: Intraoperative, 30 minutes after the first nail insertion.
The surgical field visualization for osteotomy
measured by Fromme's operative visibility scale (0-5) ,5: Massive uncontrollable bleeding, Surgery impossible. 4: Heavy but controllable. 3: Moderate bleeding , 2: Moderate bleeding but without interference with accurate dissection. 1: Bleeding, so mild, No suctioning. 0: No bleeding,
Measured: Intraoperative, 20 minutes after the first osteotomy
The operative duration
minutes, from the start of anesthesia induction to extubation times
Measured: Intraoperative
The number of blood transfusion unites.
unites of packed red blood cells
Measured: intraoperative
Nitroglycerin consumption
milligram
Measured: Intraoperative
Fentanyl consumption
microgram
Measured: intraoperative
Atracurium consumption
milligram
Measured: intraoperative
Propranolol consumption
milligram
Measured: intraoperative
Mean blood pressure (MBP)
millimeter mercury
Measured: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.
Mean heart rate (HR)
beats per minute
Measured: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.
Inhalational isoflurane concentration
percent
Measured: intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction.
The number of hypertensive episodes
defined as more than 25% rise of MBP than the basal, provided as total number
Measured: intraoperative
The number of tachycardic episodes
defined as more than 25% rise of HR than the basal, provided as total number
Measured: intraoperative
Ephedrine consumption
milligram
Measured: intraoperative
The total amount of fluid utilization.
milliliter
Measured: intraoperative
Visual analog score
scale (0-10), 0= no pain
Measured: postoperative at 1,4,8,12,16, 20, 24 hours
the time to first analgesic request
minutes
Measured: postoperative for 24 hours
Opioid request episodes
number
Measured: postoperative for 24 hours
Ambulation time
hours to the time of first standing alone after the operation.
Measured: postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours.
Hospital stay
days until the discharge time with the ability to walk, eat, controlled pain.
Measured: postoperative, till the time of signed discharge order. up to 10 days
the Incidence of wound complications.
infection, dehiscence, seroma, hematoma, bleeding
Measured: postoperative till 2 weeks
Surgeon satisfaction with the operative filed
score (0-10), 10 is the best
Measured: within 2 hours from the end of operation
Patient satisfaction with analgesia
score (0-10), 10 is the best
Measured: 24 hours after the end of surgery
Urine output
milliliter
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start11 Apr 2017
- Primary completion10 Oct 2017
- Study completion10 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Spine SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mazy Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03319563
- Sponsor's protocol ID
- R/17.02.85
- Other IDs
- PACTR201703002123104
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Volume, Multilevel Local Anesthetic-Epinephrine Infiltration in Kyphoscoliosis Surgery: Blood Conservation and Analgesia
- ClinicalTrials.gov ID
- NCT03319563
- Acronym / sponsor ID
- R/17.02.85
- Conditions
- Posterior Spine Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- 10 Oct 2017 (actual)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| local anesthetic-epinephrine group | Experimental | Drug: Local anesthetic-epinephrineafter general anesthesia, the Infiltration cocktail was done by the surgeon at three levels: 1. Subcutaneous: before incision at a volume 20 ml/10 cm/side. 2. Muscular Paravertebral: before opening the thoracolumbar fascia, using the same previous volume. 3. Neural paravertebral: after exposure of the transverse processes. A volume of 5 ml/per each process of the same cocktail, 1 cm deep to the surface of the corresponding process before pedicular screws fixation after negative blood aspiration. |
| saline group | Placebo comparator | Drug: Salineafter general anesthesia, the same infiltration volume and technique using normal saline. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Kyphoscoliosis patients subjected for spinal correction.
- Age 8-18 years.
- American Society of Anesthesiologists I-II status.
Key exclusion criteria (7 listed)
- Patient or parents refusal.
- Infection at surgical site.
- Hypersensitivity to amide local anesthetics.
- Coagulopathy.
- Blood diseases as sickle cell anemia, hemophilia, idiopathic thrombocytopenic purpura.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local anesthetic-epinephrineAlso: infiltration group* 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 | local anesthetic-epinephrine group |
| SalineAlso: control groupnormal saline 100 ml/10 cm of the wound length | Drug | saline group |
Primary outcome
Estimated blood loss
Time frame: Intraoperative
milliliter
Total Morphine consumption.
Time frame: during first 24 hours postoperatively.
milligram
26 secondary outcomes
The surgical field visualization for subcutaneous incision
Time frame: Intraoperative, 10 minutes after skin incision.
The surgical field visualization for muscular dissection
Time frame: Intraoperative, 30 minutes after the thoracolumbar fascia incision,
The surgical field visualization for nails insertion
Time frame: Intraoperative, 30 minutes after the first nail insertion.
The surgical field visualization for osteotomy
Time frame: Intraoperative, 20 minutes after the first osteotomy
The operative duration
Time frame: Intraoperative
The number of blood transfusion unites.
Time frame: intraoperative
Nitroglycerin consumption
Time frame: Intraoperative
Fentanyl consumption
Time frame: intraoperative
Atracurium consumption
Time frame: intraoperative
Propranolol consumption
Time frame: intraoperative
Mean blood pressure (MBP)
Time frame: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.
Mean heart rate (HR)
Time frame: basal, 5 minutes after the onsite of infiltration, 3 minutes after the onsite of skin incision, then after 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia.
Inhalational isoflurane concentration
Time frame: intraoperative: at 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes from the start of anesthesia induction.
The number of hypertensive episodes
Time frame: intraoperative
The number of tachycardic episodes
Time frame: intraoperative
Ephedrine consumption
Time frame: intraoperative
The total amount of fluid utilization.
Time frame: intraoperative
Visual analog score
Time frame: postoperative at 1,4,8,12,16, 20, 24 hours
the time to first analgesic request
Time frame: postoperative for 24 hours
Opioid request episodes
Time frame: postoperative for 24 hours
Ambulation time
Time frame: postoperative, the first test after 12 hours, then every 8 hours, up to 72 hours.
Hospital stay
Time frame: postoperative, till the time of signed discharge order. up to 10 days
the Incidence of wound complications.
Time frame: postoperative till 2 weeks
Surgeon satisfaction with the operative filed
Time frame: within 2 hours from the end of operation
Patient satisfaction with analgesia
Time frame: 24 hours after the end of surgery
Urine output
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: Yes. after publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local anesthetic-epinephrine and Saline in people with Posterior Spine Surgery, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (time frame: Intraoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.