Postoperative PainPhase 3NCT00405262
A Comparison of Bupivacaine and Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting
A Phase 3 study testing Ketorolac, Bupivacaine and ketorolac + bupivacaine in people with Postoperative Pain, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketorolac, Bupivacaine and ketorolac + bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- May 2006to Oct 2008
- Phase
- Phase 3
- 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 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Alveolar bone graft patients age 10-13 years of age
- Lefort I osteotomy patients needing ICBG age 14 to 20 years
- able to operate a patient-controlled analgesia (PCA) device
Who cannot join
- Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
- Allergy, sensitivity or contraindication to morphine
- History of gastric ulcer or bleeding diathesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Bupivicaine Infusion Versus Intravenous Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting for Lefort I Osteotomy or Alveolar Cleft Repair.
The efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain.
Read the detailed description
Iliac crest bone grafts (ICBG) are used for many types of surgeries including alveolar cleft repair, Lefort I osteotomies, spinal fusion, and fracture management. ICBG donor sites are notoriously painful, and the pain is often more severe than that from the primary operative site.
Postoperative pain management after operations that involve harvesting ICBG usually includes opioids, which are most often delivered by a patient-controlled device. Additional analgesics may include acetaminophen, non-steroidal anti-inflammatory (NSAID) drugs, and local anesthetic agents, such as bupivacaine or ropivacaine. Local anesthetics may also be injected intermittently or continuously into the wound via an indwelling catheter inserted at the time of surgery. All but one of these studies have shown a significant reduction in pain scores and opioid consumption using local anesthetic through an indwelling catheter.
Only one study has investigated the effects of NSAIDs on postoperative ICBG pain. This study found that intravenous ketorolac did not reduce morphine consumption. However, there was a trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not measured.
Currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter for patients at our institution undergoing Lefort I osteotomy or alveolar cleft repair with ICBG since we find the above pain management regimen to be effective, with most patients using low to moderate amounts of morphine. To our knowledge, no study to date has compared the efficacy of ketorolac to local anesthetic infusions for patients undergoing Lefort I osteotomy or alveolar cleft repair with ICBG.
- Conditions
- Postoperative Pain
- Being tested
- Ketorolac, Bupivacaine, ketorolac + bupivacaine
- Keywords
- Pediatrics, Postoperative Analgesia, orthopedic surgery, Iliac Crest Bone Graft, Osteotomy, cleft palate
- Medical subject headings
- Pain, Postoperative, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
BupivacaineDrug
0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
ketorolac + bupivacaineDrug
0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours.
For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Ketorolac |
| 2 | Experimental | Not described Receives: Drug: Bupivacaine |
| 3 | Experimental | Not described Receives: Drug: ketorolac + bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain, assessed with a numerical analog system
Measured: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours
Patient satisfaction score
Measured: 24 hours
Secondary outcomes (9)
Morphine consumption
Measured: Every 4 hours
Total number of episodes of nausea, vomiting, and pruritis
Measured: 48 hours
Doses of all anti-emetics
Measured: 48 hours
Heart rate and respiratory rate variables
Measured: 48 hours
Time to first ambulation
Measured: Time determined by outcome
Wound healing at iliac crest site
Measured: 1, 4, 8 and 16 weeks post-operatively
X-ray data on recipient site
Measured: 1, 4, 8 and 16 weeks post-operatively
Clinical assessment of recipient site
Measured: 1, 4, 8 and 16 weeks post-operatively
Plasma bupivacaine levels
Measured: Before bolus and at 0.5, 1, 6, 12 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hayes, The Hospital for Sick Children
- Investigators
- Jason Hayes, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405262
- Sponsor's protocol ID
- 1000008719
- Status last verified
- Aug 2013
- First submitted
- 28 Nov 2006
- Last updated
- 20 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayes JA, Forrest CR, Walsh W, Petroz GC, Adeli K, Bissonnette B. Continuous bupivacaine infusion post-iliac crest bone graft harvesting in pediatric cleft surgery: role and comparison with ketorolac. Cleft Palate Craniofac J. 2011 Sep;48(5):532-7. doi: 10.1597/10-148. Epub 2010 Nov 23.
PubMed 21091369
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Bupivicaine Infusion Versus Intravenous Ketorolac for Postoperative Analgesia After Iliac Crest Bone Harvesting for Lefort I Osteotomy or Alveolar Cleft Repair.
- ClinicalTrials.gov ID
- NCT00405262
- Acronym / sponsor ID
- 1000008719
- Conditions
- Postoperative Pain
- Keywords
- Pediatrics, Postoperative Analgesia, orthopedic surgery, Iliac Crest Bone Graft, Osteotomy, cleft palate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Nov 2006 (estimated)
- 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 efficacy of three postoperative pain management regimens will be compared in patients undergoing Lefort I osteotomy or alveolar cleft repair with Iliac crest bone grafts (ICBG) to determine the best way of managing postoperative pain.
Detailed description
Iliac crest bone grafts (ICBG) are used for many types of surgeries including alveolar cleft repair, Lefort I osteotomies, spinal fusion, and fracture management. ICBG donor sites are notoriously painful, and the pain is often more severe than that from the primary operative site.
Postoperative pain management after operations that involve harvesting ICBG usually includes opioids, which are most often delivered by a patient-controlled device. Additional analgesics may include acetaminophen, non-steroidal anti-inflammatory (NSAID) drugs, and local anesthetic agents, such as bupivacaine or ropivacaine. Local anesthetics may also be injected intermittently or continuously into the wound via an indwelling catheter inserted at the time of surgery. All but one of these studies have shown a significant reduction in pain scores and opioid consumption using local anesthetic through an indwelling catheter.
Only one study has investigated the effects of NSAIDs on postoperative ICBG pain. This study found that intravenous ketorolac did not reduce morphine consumption. However, there was a trend to lower morphine use with ketorolac, and pain and patient satisfaction scores were not measured.
Currently, we do not use local anesthetic infusions via an indwelling iliac crest catheter for patients at our institution undergoing Lefort I osteotomy or alveolar cleft repair with ICBG since we find the above pain management regimen to be effective, with most patients using low to moderate amounts of morphine. To our knowledge, no study to date has compared the efficacy of ketorolac to local anesthetic infusions for patients undergoing Lefort I osteotomy or alveolar cleft repair with ICBG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Ketorolac |
| 2 | Experimental | Drug: Bupivacaine |
| 3 | Experimental | Drug: ketorolac + bupivacaine |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Alveolar bone graft patients age 10-13 years of age
- Lefort I osteotomy patients needing ICBG age 14 to 20 years
- able to operate a patient-controlled analgesia (PCA) device
Key exclusion criteria (3 listed)
- Allergy, sensitivity or contraindication to any non-steroidal anti-inflammatory drugs
- Allergy, sensitivity or contraindication to morphine
- History of gastric ulcer or bleeding diathesis
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 |
|---|---|---|
| Ketorolac0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter | Drug | 1 |
| Bupivacaine0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours. | Drug | 2 |
| ketorolac + bupivacaine0.2 mL•kg-1 (lean body mass) bolus of bupivacaine 0.25% with epinephrine 1:200 000 will be injected through the IC catheter at the end surgery before the patient's trachea is extubated to detect intravascular injection. An infusion of the same solution will be started at 0.1 mL•kg-1•hour-1 (lean body mass) for 24 hours. For ketorolac, patients will receive 0.5 mg•kg-1 IV at the end of surgery before extubation and then 3 additional doses every 8 hours thereafter | Drug | 3 |
Primary outcome
Pain, assessed with a numerical analog system
Time frame: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours
Patient satisfaction score
Time frame: 24 hours
9 secondary outcomes
Morphine consumption
Time frame: Every 4 hours
Total number of episodes of nausea, vomiting, and pruritis
Time frame: 48 hours
Doses of all anti-emetics
Time frame: 48 hours
Heart rate and respiratory rate variables
Time frame: 48 hours
Time to first ambulation
Time frame: Time determined by outcome
Wound healing at iliac crest site
Time frame: 1, 4, 8 and 16 weeks post-operatively
X-ray data on recipient site
Time frame: 1, 4, 8 and 16 weeks post-operatively
Clinical assessment of recipient site
Time frame: 1, 4, 8 and 16 weeks post-operatively
Plasma bupivacaine levels
Time frame: Before bolus and at 0.5, 1, 6, 12 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
- Derived from this study: PubMed 21091369Hayes JA, Forrest CR, Walsh W, Petroz GC, Adeli K, Bissonnette B. Continuous bupivacaine infusion post-iliac crest bone graft harvesting in pediatric cleft surgery: role and comparison with ketorolac. Cleft Palate Craniofac J. 2011 Sep;48(5):532-7. doi: 10.1597/10-148. Epub 2010 Nov 23.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Jason Hayes, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketorolac, Bupivacaine and ketorolac + bupivacaine in people with Postoperative Pain, run by The Hospital for Sick Children at 1 site in Canada.
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 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: finished, as of the sponsor's last update on 20 Aug 2013. 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 Canada. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, assessed with a numerical analog system (time frame: As soon as the patient is able to respond appropriately and then approximately every 4 hours for 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00405262, which also lists 1 linked publication.
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 20 Aug 2013.