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Autogenous Bone GraftsPhase 4NCT01037335

Effect of Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest

A Phase 4 study testing morphine in people with Autogenous Bone Grafts, run by The Cleveland Clinic.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The goal of the current study was to evaluate the analgesic efficacy of low-dose morphine administered to the site of bone graft harvesting in patients undergoing orthopedic surgery. In addition to short-term analgesic effects, the incidence of chronic donor site pain was evaluated 1,3,6 m after surgery. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Autogenous Bone Grafts
What is being tested?
morphine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Apr 2009to Mar 2017
Phase
Phase 4
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Patients on opioids
  • Neuropathic disease
  • Chronic conditions

About this study

Official title: Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest

The goal of the current study was to evaluate the analgesic efficacy of low-dose morphine administered to the site of bone graft harvesting in patients undergoing orthopedic surgery. In addition to short-term analgesic effects, the incidence of chronic donor site pain was evaluated 1,3,6 m after surgery.

Read the detailed description

The protocol is approved by the Institutional Review Board at Gülhane Military Medical Academy Haydarpaşa Training Hospital (Istanbul, Turkey) and written informed consent will be obtained from each patient. Sixty adult patients scheduled to undergo elective upper extremity bone fractures using autogenous bone grafts will be enrolled in this prospective, randomized, double-blind study. Patients were eligible for participation if they were greater than 18 yr of age, they weighed more than 40 kg, they were American Society of Anesthesiologists physical status I or II, and they could operate a patient-controlled analgesia (PCA) device and had no allergies to morphine.

All surgical procedures will be performed using a partial thickness posterior iliac crest bone graft harvested through a lateral oblique incision just cephalad to the crest. Anesthesia was induced with 2 mg/kg propofol and 5 mg/kg fentanyl and maintained with sevoflurane in 50% oxygen in air. After the graft was harvested and hemostasis will be achieved, patients will be randomly assigned to one of three treatment groups using a computer- generated random number table. Group 1 (control group) was given 10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly. Group 2 (intramuscular morphine) was given 10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly. Group 3 (donor site morphine) was given 5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly. All intramuscular injections were administered in the deltoid muscle at the same time as harvest site infiltration. The study medications were prepared by the pharmacy and administered by the surgeon and anesthesiologist, who were blinded to their contents. In the recovery room, patients were connected to a PCA pump (Abbott PCA Plus, Abbott Laboratories, North Chicago, IL) containing 1 mg/ml morphine. The initial settings were an incremental dose of 1.5 ml, a lockout interval of 8 min, and a 4-h limit of 30 ml. The incremental dose was increased to 2.0 ml and the 4-h limit was increased to 45 ml if analgesia was inadequate after 1 h. If analgesia was inadequate after an additional hour, the incremental dose was further increased to 2.5 ml. Patients were asked to quantify their pain from both the donor and the upper extremity surgery incision sites on a verbal analog pain scale of 0-10, with 0 representing no pain and 10 the worst imaginable pain. Pain assessments were made by a blinded research nurse observer 2, 4, 6, 8, 12, and 24 h after completion of surgery. In addition, PCA morphine use was recorded at these six time intervals. Analgesic duration was defined as the time from local administration of study drug to the first requirement of PCA morphine. At 1m, 3 m and 6 m yr after surgery, patients will be interviewed by telephone by a blinded investigator, and a detailed questionnaire similar to that reported in a previous study on donor site pain will be completed. The presence and subjective characteristics of any residual donor site pain, including its quality, severity, and frequency, as well as provoking factors and treatment received, will be recorded.

Being tested
morphine
Keywords
bone graft, pain, chronic
Medical subject headings
Pain, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • morphineDrug

    Group 1 (control group) was given 10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly. Group 2 (intramuscular morphine) was given 10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly. Group 3 (donor site morphine) was given 5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.

Study groups in NCT01037335
Study groupRoleWhat they receive
control groupPlacebo comparator10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly.
Receives: Drug: morphine
intramuscular morphineActive comparator10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly
Receives: Drug: morphine
donor site morphineActive comparator5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.
Receives: Drug: morphine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain after procedure

    Measured: first 24 hrs

Secondary outcomes (1)
  1. chronic pain formation

    Measured: 1,3 and 6m

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionMar 2017
  4. Study completionMar 2017

Why it stopped: No participants enrolled

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01037335
Sponsor's protocol ID
GATA 1 123
Status last verified
Apr 2017
First submitted
22 Dec 2009
Last updated
13 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing morphine in people with Autogenous Bone Grafts, run by The Cleveland Clinic.

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 0 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

pain after procedure (time frame: first 24 hrs). 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 13 Apr 2017.

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