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Poor response rate on follow up of patients
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Context:
Single shot peripheral nerve blocks have limited duration of action depending on the local anesthetic agent used in the block. But it rarely lasts longer than 12 hrs. Patients need oral analgesics at home once the block wears off to control the pain.
Objectives:
Primary Objective
To determine if peripheral nerve blocks have any advantage in terms of decreasing oral analgesic requirements in the post operative period even after the effects of the block have worn off
Secondary Objective
To determine if inclusion of single shot regional technique improves patient/family satisfaction with post operative pain management .
Study Design:
Prospective randomized single blinded study.
Inclusion Criteria
Exclusion Criteria
80 children between the ages of 6yr and 17 yrs. scheduled for ambulatory peripheral orthopedic procedures in the operating rooms of Batson Children's Hospital will be enrolled in the study. Written informed consent will be obtained from the parents or legal guardian and assent will be obtained from patients when possible.
Once enrolled in the study, patients will be randomly assigned to one of two groups General anesthesia only (GA group) and General Anesthesia combined with regional anesthesia (RA group). Once the patients are brought to the operating room standard ASA monitors will be applied. After mask induction with O2/Nitrous oxide(N2O)/Sevoflurane(Sevo), a peripheral intravenous line will be inserted and secured. Additional IV medication propofol 2-3mg/kg will be given prior to insertion of appropriate size laryngeal mask airway (LMA). Patients in GA group will undergo the procedure under general anesthesia with Sevo/O2. Patients in the RA group will receive a peripheral nerve block appropriate for the procedure after induction of general anesthesia with O2/N2O/Sevo. The attending anesthesiologists will perform the nerve block under ultrasound guidance (Sonosite machine with high frequency probe) using 22G stimulating needle under aseptic precautions. 0.5% ropivacaine up to a total dose of 3mg/kg will be used for the block.
Anesthesia is maintained in both groups with O2/Sevo titrated to minimum alveolar concentration (MAC of) 1.5 . After surgical incision, doses of 0.05mg/kg morphine is given IV every 5 min as needed titrated to HR and BP within 10% change from baseline.
Additional IV morphine at the dose of 0.05mg/kg will be given every 10 minutes in the recovery room (PACU) as needed for pain ( Visual Analog score -VAS score >4). Total morphine consumption, length of recovery room stay and side effects such as nausea or vomiting will be recorded in the PACU.
The patients in the study will be given the following
The parents will be educated about assessing pain and visual analog scale score. The parents will be instructed to give one or two pills depending on the weight (one pill for weight <50kg and 2 pills for weight >50kg)every 4-6 hrs. as needed for pain (VAS score more than 2).
The patients will be followed by phone by research nurse blinded to the group on postoperative day 2 and day 8. They will be asked about the total use of analgesics at the end of day 2 (first 48hrs) and day 7. Family satisfaction on a scale of 1 to10, Incidence of other side effects such as nausea, vomiting, sleep disturbance, feeding difficulty and prolonged numbness or motor block will also be collected.
The parents will also be requested to return the data sheet in the stamped return envelope to the research team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General | Active Comparator | General Anesthesia only |
|
| Regional | Experimental | General Anesthesia combined with regional block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regional block | Procedure | Single shot peripheral nerve block |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Hydrocodone Dose (mg/kg) | day 2 and day 8 after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Patient/Family Satisfaction With Pain Management | Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery. | one week after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| madhankumar sathyamoorthy, MBBS, MS | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22786464 | Background | Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38. | |
| 18498436 | Background | Segerdahl M, Warren-Stomberg M, Rawal N, Brattwall M, Jakobsson J. Children in day surgery: clinical practice and routines. The results from a nation-wide survey. Acta Anaesthesiol Scand. 2008 Jul;52(6):821-8. doi: 10.1111/j.1399-6576.2008.01669.x. Epub 2008 May 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | General | General Anesthesia only General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane Opioids Morphine: Morphine Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone |
| FG001 | Regional |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| General Anesthesia |
| Procedure |
General Anesthesia with O2/N2O/Sevoflurane |
|
| Local Anesthetic Ropivacaine | Drug | 0.5% Ropivacaine |
|
| Opioids Morphine | Drug | Morphine |
|
| Oral pain medication Acetaminophen with Hydrocodone | Drug | Acetaminophen with Hydrocodone |
|
| 24330523 | Background | Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11. |
| 24407716 | Background | Brasher C, Gafsous B, Dugue S, Thiollier A, Kinderf J, Nivoche Y, Grace R, Dahmani S. Postoperative pain management in children and infants: an update. Paediatr Drugs. 2014 Apr;16(2):129-40. doi: 10.1007/s40272-013-0062-0. |
| 21895855 | Background | Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available. |
| 21951324 | Background | Polaner DM, Martin LD; PRAN Investigators. Quality assurance and improvement: the Pediatric Regional Anesthesia Network. Paediatr Anaesth. 2012 Jan;22(1):115-9. doi: 10.1111/j.1460-9592.2011.03708.x. Epub 2011 Sep 27. |
| 21199114 | Background | Ecoffey C, Lacroix F, Giaufre E, Orliaguet G, Courreges P; Association des Anesthesistes Reanimateurs Pediatriques d'Expression Francaise (ADARPEF). Epidemiology and morbidity of regional anesthesia in children: a follow-up one-year prospective survey of the French-Language Society of Paediatric Anaesthesiologists (ADARPEF). Paediatr Anaesth. 2010 Dec;20(12):1061-9. doi: 10.1111/j.1460-9592.2010.03448.x. |
General Anesthesia combined with regional block
Regional block: Single shot peripheral nerve block
General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane
Local Anesthetic Ropivacaine: 0.5% Ropivacaine
Opioids Morphine: Morphine
Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | General | General Anesthesia only General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane Opioids Morphine: Morphine Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone |
| BG001 | Regional | General Anesthesia combined with regional block Regional block: Single shot peripheral nerve block General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane Local Anesthetic Ropivacaine: 0.5% Ropivacaine Opioids Morphine: Morphine Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Hydrocodone Dose (mg/kg) | Posted | Mean | Standard Deviation | mg/kg | day 2 and day 8 after the surgery |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Patient/Family Satisfaction With Pain Management | Patient/family satisfaction on a scale of 1 to 10 with 1 least satisfied and 10 completely satisfied. Family will complete the form and return to the primary investigator at the end of day 8 after surgery in the prepaid envelope provided to them at the time of the surgery. | Posted | Count of Participants | Participants | one week after the surgery |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | General | General Anesthesia only General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane Opioids Morphine: Morphine Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone | 0 | 22 | 0 | 22 | ||
| EG001 | Regional | General Anesthesia combined with regional block Regional block: Single shot peripheral nerve block General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane Local Anesthetic Ropivacaine: 0.5% Ropivacaine Opioids Morphine: Morphine Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone | 0 | 27 | 0 | 27 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Madhankumar Sathyamoorthy | University of Mississippi Medical Center | 6018157066 | msathyamoorthy@umc.edu |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
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| >=65 years |
|
| Male |
|
|