- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01037335
Effect of Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest
Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest
Study Overview
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.
Study Type
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Exclusion Criteria:
- Patients on opioids
- Neuropathic disease
- Chronic conditions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: control group
10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly.
|
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.
|
Active Comparator: intramuscular morphine
10 ml NS infiltrated into the harvest site and 5 mg morphine (1 ml) intramuscularly
|
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.
|
Active Comparator: donor site morphine
5 mg morphine (10 ml) infiltrated into the harvest site and 1 ml NS intramuscularly.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain after procedure
Time Frame: first 24 hrs
|
first 24 hrs
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
chronic pain formation
Time Frame: 1,3 and 6m
|
1,3 and 6m
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: alparslan turan, md, cleveland Clinic, outcomes research
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GATA 1 123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autogenous Bone Grafts
-
Cairo UniversityNot yet recruitingImmediate Implant | Autogenous Tooth Graft | Estetic Zone | Autogenous Bone Graft | Jumping Gap | Crestal Bone LevelEgypt
-
BonusBio Group LtdRecruitingBone Augmentation | Bone GraftsIsrael
-
Cairo UniversityCompletedAlveolar Ridge Preservation | Dentin Graft | Autogenous Tooth Bone GraftEgypt
-
University of Sao PauloCompletedInfluence of Low-level Laser Therapy on Stability and Displacement of Orthodontic Miniscrew ImplantsDisplacement of Other Bone Devices, Implants and Grafts | Mechanical Complication of Other Bone Devices, Implants and Grafts
-
Tufts UniversityNot yet recruitingDental Implant | Bone Substitute | Maxillary Sinus Floor Augmentation | Autogenous Bone GraftUnited States
-
Kafrelsheikh UniversityCompletedSimvastatin | Immediate Implant Placement | Autogenous Tooth Bone GraftEgypt
-
Dalia Rasheed IssaCompletedImmediate Implant Placement | Autogenous Tooth Bone Graft | L-PRFEgypt
-
fang guofangUnknownDefect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone GraftChina
-
Cairo UniversityCompletedCustomized Healing Abutment Bone Grafts Connective Tissue Graft Immediate Implant PlacementEgypt
-
NYU Langone HealthCompleted
Clinical Trials on morphine
-
Indiana UniversityCompletedNeonatal Abstinence Syndrome | Neonatal Opioid Withdrawal Syndrome | Neonatal Opioid WithdrawalUnited States
-
Javelin PharmaceuticalsCompleted
-
Javelin PharmaceuticalsCompletedPain, PostoperativeUnited States
-
Mahidol UniversityCompletedLung Diseases | Solitary MassThailand
-
University of MonastirCompletedTitrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)Acute Pain | Post-Traumatic HeadacheTunisia
-
University of Colorado, DenverCompletedScoliosis | Pain Management | Spinal FusionUnited States
-
Javelin PharmaceuticalsCompletedPost-Operative Pain | Third Molar Extraction
-
Cukurova UniversityCompleted
-
University College Hospital GalwayCompletedPain, Postoperative | Arthroplasty, Replacement, Knee
-
Rijnstate HospitalCompletedTotal Hip Replacement