Postoperative PainNCT04730531
Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery
A study testing Local infiltration with 0.25% bupivacaine and epinephrine in people with Postoperative Pain and Spinal Fusion, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Postoperative Pain, Spinal Fusion
- What is being tested?
- Local infiltration with 0.25% bupivacaine and epinephrine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2022to 1 Dec 2024
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≥10 years old and ≤17 years old at assessment
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
Who cannot join
- Diagnosis of neuromuscular, syndromic, or congenital scoliosis
- History of known allergy to local anesthesia
- Chronic pre-operative opioid consumptions
- Any other analgesic treatment for chronic pain before surgery
- Psychiatric or neurological disorders
- Cannot fluently read or speak English
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Lauren E Hutchinson, MPH, 617-919-1632, Lauren.Hutchinson@childrens.harvard.edu
Craig Birch, MD
About this study
Official title: Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial
Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.
- Conditions
- Postoperative Pain, Spinal Fusion
- Being tested
- Local infiltration with 0.25% bupivacaine and epinephrine, Placebo of equal volume injectable saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local infiltration with 0.25% bupivacaine and epinephrineProcedure or surgery
The local infiltration will occur in 2 stages, separated by 30 minutes. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.
Placebo of equal volume injectable salineProcedure or surgery
An equal volume of injectable saline will be used in the exact 2 stages as the treatment group. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Local infiltration with 0.25% bupivacaine and epinephrine Receives: Procedure: Local infiltration with 0.25% bupivacaine and epinephrine |
| Control Arm | Placebo comparator | Placebo of equal volume injectable saline Receives: Procedure: Placebo of equal volume injectable saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain score
The average Visual Analog Scale pain score (on a scale of 0-100 mm) during the first 24 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual.
Measured: 24 hours post-operatively
Secondary outcomes (2)
Average use of morphine equivalents
The average use of morphine equivalents per kilogram during the first 24 hours postoperatively. Morphine equivalents per kilogram will be also be obtained by reviewing post-anesthesia care unit reports.
Measured: 24 hours post-operatively
Scoliosis Patient Questionnaire - Version 30 (SRS-30)
SRS-30 scores at 1-, 6-, and 12-months post-operatively. The Scoliosis Research Society (SRS-30) questionnaire is a 30-question patient reported instrument developed to evaluate health-related quality of life in patients with scoliosis. Scores from the SRS-30 are compiled into five domain scores: pain, function, self-image, mental health and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome.
Measured: 1-, 6-, and 12-months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start2 Jun 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Birch, Boston Children's Hospital
- Investigators
- Craig Birch, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04730531
- Sponsor's protocol ID
- IRB-P00037508
- Status last verified
- Aug 2022
- First submitted
- 26 Jan 2021
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04730531
- Acronym / sponsor ID
- IRB-P00037508
- Conditions
- Postoperative Pain, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 2 Jun 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 29 Jan 2021 (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.
Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Procedure: Local infiltration with 0.25% bupivacaine and epinephrineLocal infiltration with 0.25% bupivacaine and epinephrine |
| Control Arm | Placebo comparator | Procedure: Placebo of equal volume injectable salinePlacebo of equal volume injectable saline |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≥10 years old and ≤17 years old at assessment
- Diagnosis of Adolescent Idiopathic Scoliosis (AIS)
- Planned surgical treatment of progressive spinal deformity with posterior spinal fusion
Key exclusion criteria (6 listed)
- Diagnosis of neuromuscular, syndromic, or congenital scoliosis
- History of known allergy to local anesthesia
- Chronic pre-operative opioid consumptions
- Any other analgesic treatment for chronic pain before surgery
- Psychiatric or neurological disorders
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 infiltration with 0.25% bupivacaine and epinephrineThe local infiltration will occur in 2 stages, separated by 30 minutes. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin. | Procedure or surgery | Treatment Arm |
| Placebo of equal volume injectable salineAn equal volume of injectable saline will be used in the exact 2 stages as the treatment group. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin. | Procedure or surgery | Control Arm |
Primary outcome
Visual Analog Scale (VAS) pain score
Time frame: 24 hours post-operatively
The average Visual Analog Scale pain score (on a scale of 0-100 mm) during the first 24 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual.
2 secondary outcomes
Average use of morphine equivalents
Time frame: 24 hours post-operatively
Scoliosis Patient Questionnaire - Version 30 (SRS-30)
Time frame: 1-, 6-, and 12-months post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Craig Birch, MD principal investigator
Boston Children's Hospital
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 infiltration with 0.25% bupivacaine and epinephrine in people with Postoperative Pain and Spinal Fusion, run by Boston Children's Hospital at 1 site in United States.
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 6 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lauren E Hutchinson, MPH ((617) 919-1632 ext. 91632, Lauren.Hutchinson@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) pain score (time frame: 24 hours post-operatively). 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 Aug 2022.