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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Outcomes Research Consortium.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
The Cleveland Clinic
Haydarpasa Numune Training and Research Hospital
Information provided by:
Outcomes Research Consortium
ClinicalTrials.gov Identifier:
NCT01037335
First received: December 22, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Autogenous Bone Grafts
Drug: morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Local Administration of Morphine for Analgesia After Iliac Bone Graft Harvest

Resource links provided by NLM:


Further study details as provided by Outcomes Research Consortium:

Primary Outcome Measures:
  • pain after procedure [ Time Frame: first 24 hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • chronic pain formation [ Time Frame: 1,3 and 6m ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control group
10 ml normal saline (NS) infiltrated into the harvest site, and 1 ml NS was administered intramuscularly.
Drug: morphine
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
Drug: morphine
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.
Drug: morphine
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Exclusion Criteria:

  • Patients on opioids
  • Neuropathic disease
  • Chronic conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01037335

Contacts
Contact: huseyin sen, md 90 216 5422020 drhuseyinsen@hotmail.com
Contact: alparslan turan, md 216 4459857 alparslanturan@yahoo.com

Locations
Turkey
GATA Haydarpasa Egitim Hastanesi Anestezi ve Reanimasyon Klinigi Uskudar, Recruiting
Istanbul, Turkey
Contact: Huseyin Sen,, md    90 216 5422020    drhuseyinsen@hotmail.com   
Sponsors and Collaborators
Outcomes Research Consortium
The Cleveland Clinic
Haydarpasa Numune Training and Research Hospital
Investigators
Study Director: alparslan turan, md cleveland Clinic, outcomes research
  More Information

No publications provided

Responsible Party: Dr. Huseyin Sen,, GATA Haydarpasa Egitim Hastanesi Anestezi ve Reanimasyon Klinigi Uskudar,
ClinicalTrials.gov Identifier: NCT01037335     History of Changes
Other Study ID Numbers: GATA 1 123
Study First Received: December 22, 2009
Last Updated: December 22, 2009
Health Authority: Turkey: Ethics Committee

Keywords provided by Outcomes Research Consortium:
bone graft
pain
chronic

Additional relevant MeSH terms:
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on April 16, 2014