Spine SurgeryPhase 2NCT07201987
Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes
A Phase 2 study testing Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads) and Bupivacaine (local, via calcium sulfate beads) in people with Spine Surgery and Postoperative Pain Management, run by Ganesh M. Shankar.
Trial summary
The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Surgery, Postoperative Pain Management
- What is being tested?
- Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads) and Bupivacaine (local, via calcium sulfate beads)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to 1 Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Able to understand and provide consent in English
- Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels
Who cannot join
- History of allergy or hypersensitivity to morphine, bupivacaine, or calcium sulfate.
- Active systemic or localized infection at the surgical site.
- History of chronic opioid dependence or opioid use disorder (as it may confound pain assessment).
- Patients with severe renal or hepatic impairment (due to altered metabolism of analgesics and risk of complications from analgesic side effects).
- Pregnant or breastfeeding individuals.
- Filling of defects that are intrinsic to the stability of the bony structure
Show all 10Show fewer
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative bone disease
- Hypercalcemia
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines.
Researchers want to know if the sustained release formulation of morphine from these calcium sulfate beads affect:
Read more
- Postoperative length of stay
- Postoperative pain scores
- Postoperative narcotic analgesic requirements
All participants in this study will already be scheduled to have spine surgery as part of their regular medical care. During surgery, participants will be assigned to receive either intraoperative placement of calcium sulfate beads with vancomycin alone or vancomycin with morphine and bupivacaine. All patients will still have access to standard of care with IV and PO pain regimens. Participants will then be followed after surgery to measure their pain, recovery, and medication use.
Participation is voluntary, and choosing not to join will not affect a person's medical care.
- Conditions
- Spine Surgery, Postoperative Pain Management
- Being tested
- Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads), Bupivacaine (local, via calcium sulfate beads)
- Keywords
- Spine surgery, Postoperative pain management, Calcium sulfate beads, Vancomycin, Analgesics, Hospital length of stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin (local, via calcium sulfate beads)Drug
Patients undergoing spine surgery will receive intraoperative placement of calcium sulfate beads impregnated with vancomycin. The beads are intended to provide local infection prophylaxis.
Morphine (local, via calcium sulfate beads)Drug
Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with morphine. The beads are intended to provide sustained local analgesia.
Bupivacaine (local, via calcium sulfate beads)Drug
Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with bupivacaine. The beads are intended to provide sustained local analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine | Experimental | Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads conjugated with morphine and bupivacaine for pain control, in addition to standard perioperative care. Receives: Drug: Vancomycin (local, via calcium sulfate beads); Drug: Morphine (local, via calcium sulfate beads); Drug: Bupivacaine (local, via calcium sulfate beads) |
| Vancomycin-impregnated calcium sulfate beads (standard-of-care) | Active comparator | Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics. Receives: Drug: Vancomycin (local, via calcium sulfate beads) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)
Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents.
Measured: From end of surgery through 8 weeks post-surgery.
Change from Baseline in Postoperative Pain Intensity as Measured by PROMIS Pain Intensity Short Form 3a
Average change in self-reported pain intensity using the PROMIS Pain Intensity Short Form 3a, scored on a 0-10 scale (0 = no pain, 10 = worst possible pain).
Measured: Baseline (pre-surgery), 24-48 hours, 2-3 weeks, and 8 weeks post-surgery.
Length of Hospital Stay
Number of days from surgery to hospital discharge.
Measured: From the day of surgery until hospital discharge (typically 2-7 days postoperatively)
Change from Baseline in Functional Status as Measured by PROMIS Physical Function Short Form 10a
Change in physical function as reported by participants using the PROMIS Physical Function Short Form 10a. Scores are reported as T-scores (mean = 50, SD = 10); higher scores indicate better function.
Measured: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI)
Change in disability as reported by participants using the Oswestry Disability Index (ODI). Scores range from 0 to 100; higher scores indicate greater disability.
Measured: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
Secondary outcomes (1)
Incidence of Surgical Site Infections
Number of participants with a postoperative surgical site infection, defined by CDC criteria.
Measured: Within 8 weeks post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine SurgeryStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganesh M. Shankar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ganesh M. Shankar, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201987
- Sponsor's protocol ID
- 2025p001993
- Status last verified
- Apr 2026
- First submitted
- 8 Sep 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the primary and secondary outcome results (including demographics, pain scores, analgesic consumption, hospital length of stay, functional outcomes, and adverse event data) will be shared. No data containing direct identifiers will be provided.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Placement of Vancomycin-impregnated Calcium Sulfate Beads Conjugated With Analgesics to Improve Spine Surgery Outcomes
- ClinicalTrials.gov ID
- NCT07201987
- Acronym / sponsor ID
- 2025p001993
- Conditions
- Spine Surgery, Postoperative Pain Management
- Keywords
- Spine surgery, Postoperative pain management, Calcium sulfate beads, Vancomycin, Analgesics, Hospital length of stay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ganesh M. ShankarUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 1 Oct 2025 (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.
The goal of this clinical trial is to learn if using calcium sulfate beads that contain vancomycin (an antibiotic) and pain-relieving medicines during spine surgery can improve recovery compared to standard care with intravenous (IV) morphine and local pain medicines.
Researchers want to know if the sustained release formulation of morphine from these calcium sulfate beads affect:
- Postoperative length of stay
- Postoperative pain scores
- Postoperative narcotic analgesic requirements
All participants in this study will already be scheduled to have spine surgery as part of their regular medical care. During surgery, participants will be assigned to receive either intraoperative placement of calcium sulfate beads with vancomycin alone or vancomycin with morphine and bupivacaine. All patients will still have access to standard of care with IV and PO pain regimens. Participants will then be followed after surgery to measure their pain, recovery, and medication use.
Participation is voluntary, and choosing not to join will not affect a person's medical care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine | Experimental | Drug: Vancomycin (local, via calcium sulfate beads), Drug: Morphine (local, via calcium sulfate beads), Drug: Bupivacaine (local, via calcium sulfate beads)Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads conjugated with morphine and bupivacaine for pain control, in addition to standard perioperative care. |
| Vancomycin-impregnated calcium sulfate beads (standard-of-care) | Active comparator | Drug: Vancomycin (local, via calcium sulfate beads)Patients will receive intraoperative placement of vancomycin-impregnated calcium sulfate beads for surgical site infection prophylaxis, without added analgesics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Able to understand and provide consent in English
- Undergoing elective lumbar spinal decompression and fusion surgery at one or two levels
Key exclusion criteria (10 listed)
- History of allergy or hypersensitivity to morphine, bupivacaine, or calcium sulfate.
- Active systemic or localized infection at the surgical site.
- History of chronic opioid dependence or opioid use disorder (as it may confound pain assessment).
- Patients with severe renal or hepatic impairment (due to altered metabolism of analgesics and risk of complications from analgesic side effects).
- Pregnant or breastfeeding individuals.
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 |
|---|---|---|
| Vancomycin (local, via calcium sulfate beads)Patients undergoing spine surgery will receive intraoperative placement of calcium sulfate beads impregnated with vancomycin. The beads are intended to provide local infection prophylaxis. | Drug | Vancomycin-impregnated calcium sulfate beads (standard-of-care), Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine |
| Morphine (local, via calcium sulfate beads)Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with morphine. The beads are intended to provide sustained local analgesia. | Drug | Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine |
| Bupivacaine (local, via calcium sulfate beads)Patients undergoing spine surgery in the experimental arm will receive intraoperative placement of calcium sulfate beads impregnated with bupivacaine. The beads are intended to provide sustained local analgesia. | Drug | Vancomycin-impregnated calcium sulfate beads with morphine and bupivacaine |
Primary outcome
Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME)
Time frame: From end of surgery through 8 weeks post-surgery.
Cumulative dose of opioids and non-opioid analgesics used postoperatively, converted to morphine milligram equivalents.
Change from Baseline in Postoperative Pain Intensity as Measured by PROMIS Pain Intensity Short Form 3a
Time frame: Baseline (pre-surgery), 24-48 hours, 2-3 weeks, and 8 weeks post-surgery.
Average change in self-reported pain intensity using the PROMIS Pain Intensity Short Form 3a, scored on a 0-10 scale (0 = no pain, 10 = worst possible pain).
Length of Hospital Stay
Time frame: From the day of surgery until hospital discharge (typically 2-7 days postoperatively)
Number of days from surgery to hospital discharge.
Change from Baseline in Functional Status as Measured by PROMIS Physical Function Short Form 10a
Time frame: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
Change in physical function as reported by participants using the PROMIS Physical Function Short Form 10a. Scores are reported as T-scores (mean = 50, SD = 10); higher scores indicate better function.
Change from Baseline in Functional Status as Measured by Oswestry Disability Index (ODI)
Time frame: Baseline (pre-surgery), 2-3 weeks, and 8 weeks post-surgery.
Change in disability as reported by participants using the Oswestry Disability Index (ODI). Scores range from 0 to 100; higher scores indicate greater disability.
1 secondary outcome
Incidence of Surgical Site Infections
Time frame: Within 8 weeks post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the primary and secondary outcome results (including demographics, pain scores, analgesic consumption, hospital length of stay, functional outcomes, and adverse event data) will be shared. No data containing direct identifiers will be provided.
Related trials for Spine Surgery
Not yet recruiting
Adding Different Doses of Dexmedetomidine to Bupivecaine in Erector Spinae Plane Block
Postoperative Pain in Lumbar Spine Surgery
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Recruiting
FIBERGRAFT Aeridyan Posterolateral Fusion Study
Degenerative Spine Disease
RecruitingPhase 4
Perioperative Rectal Methadone in Spine Surgery
Spinal Surgery, Post-operative Care
Not yet recruiting
MALMOS Technique for Selected Subaxial Cervical Spine Fractures
Cervical Spine Fractures
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vancomycin (local, via calcium sulfate beads), Morphine (local, via calcium sulfate beads) and Bupivacaine (local, via calcium sulfate beads) in people with Spine Surgery and Postoperative Pain Management, run by Ganesh M. Shankar.
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 10 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: opening soon, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ganesh Shankar, MD, PhD (617-724-1099, gshankar@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Analgesic Consumption in Morphine Milligram Equivalents (MME) (time frame: From end of surgery through 8 weeks post-surgery.). The study lists 5 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 16 Apr 2026.