Ignite Creation Date:
2024-05-06 @ 12:58 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01707251
Status:
COMPLETED
Last Update Posted:
2015-09-03
First Post:
2012-10-10
Brief Title:
Intravenous Ibuprofen for Laparoscopic Bariatric Surgery
Sponsor:
Jacobi Medical Center
Organization:
Jacobi Medical Center
Study Overview
Official Title:
Intravenous Ibuprofen for Laparoscopic Bariatric Surgery
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary objective of this study is to test hypothesis that IV ibuprofen decreases 24 hours morphine requirement using IV PCA in patients after laparoscopic bariatric surgery Secondary objective is to determine if it decreases respiratory depression measured using RD improves area under curve AUC for pain scores at rest AUCr and with cough AUCa and pressure pain threshold PPT important for mobilization Tertiary objective is to compare incidence of nauseavomiting sedation itching blood transfusion over sedation urinary retention GI or surgical bleeding renal dysfunction time to clears and baseline activity in ibuprofen and control groups
Detailed Description:
Investigators will recruit patients scheduled for laparoscopic bariatric surgery at Jacobi Medical Center 100 patients with allowance for 20 drop-offs Patients will be randomized to IV Ibuprofen versus placebo to test if morphine usage can be decreased pain control improved pressure pain thresholds increased and respiratory depression decreased
Exclusionwithdrawal criteria
Patients with history of ibuprofen or aspirin allergy morphine allergy opioid or psychotropic medication use pre-operatively patients who would show positive preoperative U-tox screening patients unable to sign consent and patients unable to understand or use patient controlled analgesia PCA or report pain intensity will be excluded Patients with GFR60 or history of GI bleed within 6 weeks will be excluded Patients will be withdrawn from the study if PCA would have to be discontinued or the patient would develop acute renal failure GI bleed or post-surgical bleed Intention to treat analysis will be performed including the dropouts
Patients instructions and protocol
Patients consented for the study will be educated about morphine PCA for pain control and about pain reporting using NRS-11 and VAS scale at rest and with cough or during incentive spirometry They will receive instructions about Remmers Sleep Recorder SagaTech Calgary Alberta Canada which includes continuous oximetry and device will be provided for overnight home screening preoperatively WhitelawWA 2005 The sleep recorder data will be reviewed pre-operatively and patients with respiratory disturbance index RDI measured as oxygen desaturation event 15hour who do not have OSA diagnosis and do not use CPAP will be referred for sleep study andor CPAP titration before the surgery Patients will be educated on QST testing using pressure algometry with 1cm2 padded tip Coronado 2010 and will be given survey questionnaire postoperative diary for self-reporting of pain VAS at rest and with cough nauseavomiting activity and side effects from medications as well as satisfaction with recovery and pain control Baseline pressure pain thresholds Ncm2 will be tested at abdomen area of postoperative hyperalgesia and the pulp of third finger finger on the right reference site using average of three measurements per site
On the day of surgery patients will be allocated to group A or B according to randomizationcom generated table for two groups with variable blocking factor Group A and B assignment to the ibuprofen versus control will be available to the pharmacy only until the completion of the study and statistical analysis
The pharmacy will store Ibuprofen and on the day of surgery will provide the covered bag of ibuprofen 800mg versus saline solution labeled with the patients name Group assignment A or B will be known to the pharmacy only IV will be started and first dose of medication will be given over 5-30 minutes preoperatively In the subgroup of patients where surgery start time is delayed by one hour or more PPT will be repeated before the start of the surgery
Patients will have standardized general anesthetic for the surgery Intraoperative opioid usage will be recorded Laparoscopic ports will be infiltrated with local anesthetic
800mg Ibuprofen or placebo infusion will be repeated every 6 hours for 24 hours postoperatively
In recovery room patients will be started on morphine patient controlled analgesia morphine PCA 05mg every 5 minutes while NPO with ability to escalate the dose up to 1 mg every 5minutes per hospital PCA protocol if patient requires additional morphine rescue to control the pain uses PCA appropriately and demonstrates no side effects Patients will have antiemetics and morphine loadingrescue dose 4mg Q15minute max 16mg per PACU nurse discretion per standard hospital protocol Patients will be continuously monitored overnight per nursing protocol and in addition to that with Remmers unit pulse oximetry respiratory effort respiratory flow airway pressure Pain score at rest and with cough and nauseavomiting will be assessed periodically and will be reported by patient in the postoperative diary Pain scores will be integrated separately over 24 hours to obtain area under curve at rest AUCr and with cough or activity AUCa Overnight oximetry recordings will be analyzed post hoc to determine RDI Patients with PCA will be monitored per hospital policy Q1h x 12h then Q2hx 12h All bariatric patients are continuously monitored overnight in the PACU or surgical step-down unit Nurses taking care of the patient routinely notify anesthesia andor surgical team about significant apneahypopnea
PCA usage log will be obtained from the pump and morphine given by the nurses will be added to calculate postoperative morphine cumulative dose for 24 hours If PCA is discontinued patient data will be analyzed as drop-off Per hospital PCA policy in the event of excessive sedation andor respiratory depression level of sedation 4 following actions are to be taken
STOP PCA PUMP stimulate patient support respirations with bag valve mask as needed
Have a coworker notify the Rapid Response Team Arrange for BMV O2 and suction
Hang Naloxone 08mg in 100ml 09 NS IVSS -continue until respirations are more than 9 bm or a total of 08mg is infused
Time 0 for the purposes of study will be time of admission to PACU PPT will be tested in the PACU in the subset of patients who are awake and wiling to perform QST testing when their pain is controlled with NRS4 QST will be repeated in qualifying patients awake pain controlled following day
In addition investigators will record
1 Transfusion requirement number of units
2 Difference between pre-operative and discharge hemoglobin
3 Requirement for surgical revision due to anastomotic leak
4 Incidence of wound infection
5 Readmission rate within 30 days
6 Preoperative and discharge GFR
7 Timed NRS-11 nurse recorded and VAS self reported for pain at rest and during cough or incentive spirometry
8 Area under the curve AUCr using NRS at rest and during incentive spirometrycough AUCa AUCr and AUCa will be separately integrated to area under curve for 24 hours
9 Total dose of morphine given by nurses for 24 hours
10 Morphine PCA usage hourly and cumulative24h
11 Presence of nauseavomiting for 24 hours
12 Antiemetic requirement number of doses
13 Time to oral tolerance clears solids hours
14 Time to bowel movement hours
15 Time patient meets discharge criteria from the PACU hours
16 Time to discharge from PACU hours
17 Time to discharge from hospital hours
18 Respiratory disturbance index baseline and postoperatively from Remmers unit
19 Incidence of desaturation to SpO295 90 and 80 baseline and postoperatively from Remmers unit Maximum FiO2 required postoperatively excluding first 2 hours immediately after surgery
20 Incidence of over sedation sedation score 3 and 4
21 Naloxone requirement if any
22 Patient satisfaction scores
23 Time to out of bed to chair hours
24 Time to stand-up hours
25 Time to ambulation hours
26 Time to baseline physical activity days
27 Max temperature
28 Incidence of DVT
29 Reason for delayed discharge 72 hours
30 Incidence of readmission within 4 weeks
31 Incidence of reoperation within 4 weeks
Data will be analyzed using commercially available statistical software
If dropouts to the study will be present intent to treat analysis will be performed
Metric scale data will be tested for normality of distribution Kolmogorov-Smirnov test Categorical data will be presented as absolute frequency and relative distribution For normally distributed data a t test for independent samples will be used to compare prepost differences between the treatment groups Otherwise a nonparametric Mann-Whitney test will be used Categorical data will be compared using chi square test or Fisher exact test for groups 5 Bonferonni correction will be done for multiple comparisons
After comparing groups for age sex BMI co morbidities surgical time baseline pressure pain thresholds investigators will investigate whether assignment into ibuprofen or saline groups makes a difference In the primary secondary and tertiary outcomes
Our null hypothesis H0 is that there will be no differences in cumulative 24h morphine consumption AUCa and AUCr for pain scores and that there will be no change in prepost difference in RDI and pressure pain thresholds In addition investigators hypothesize that there will be no difference in the incidence of nauseavomiting discharge readiness patient satisfaction among the test and control groups
Exclusionwithdrawal criteria
Patients with history of ibuprofen or aspirin allergy morphine allergy opioid or psychotropic medication use pre-operatively patients who would show positive preoperative U-tox screening patients unable to sign consent and patients unable to understand or use patient controlled analgesia PCA or report pain intensity will be excluded Patients with GFR60 or history of GI bleed within 6 weeks will be excluded Patients will be withdrawn from the study if PCA would have to be discontinued or the patient would develop acute renal failure GI bleed or post-surgical bleed Intention to treat analysis will be performed including the dropouts
Patients instructions and protocol
Patients consented for the study will be educated about morphine PCA for pain control and about pain reporting using NRS-11 and VAS scale at rest and with cough or during incentive spirometry They will receive instructions about Remmers Sleep Recorder SagaTech Calgary Alberta Canada which includes continuous oximetry and device will be provided for overnight home screening preoperatively WhitelawWA 2005 The sleep recorder data will be reviewed pre-operatively and patients with respiratory disturbance index RDI measured as oxygen desaturation event 15hour who do not have OSA diagnosis and do not use CPAP will be referred for sleep study andor CPAP titration before the surgery Patients will be educated on QST testing using pressure algometry with 1cm2 padded tip Coronado 2010 and will be given survey questionnaire postoperative diary for self-reporting of pain VAS at rest and with cough nauseavomiting activity and side effects from medications as well as satisfaction with recovery and pain control Baseline pressure pain thresholds Ncm2 will be tested at abdomen area of postoperative hyperalgesia and the pulp of third finger finger on the right reference site using average of three measurements per site
On the day of surgery patients will be allocated to group A or B according to randomizationcom generated table for two groups with variable blocking factor Group A and B assignment to the ibuprofen versus control will be available to the pharmacy only until the completion of the study and statistical analysis
The pharmacy will store Ibuprofen and on the day of surgery will provide the covered bag of ibuprofen 800mg versus saline solution labeled with the patients name Group assignment A or B will be known to the pharmacy only IV will be started and first dose of medication will be given over 5-30 minutes preoperatively In the subgroup of patients where surgery start time is delayed by one hour or more PPT will be repeated before the start of the surgery
Patients will have standardized general anesthetic for the surgery Intraoperative opioid usage will be recorded Laparoscopic ports will be infiltrated with local anesthetic
800mg Ibuprofen or placebo infusion will be repeated every 6 hours for 24 hours postoperatively
In recovery room patients will be started on morphine patient controlled analgesia morphine PCA 05mg every 5 minutes while NPO with ability to escalate the dose up to 1 mg every 5minutes per hospital PCA protocol if patient requires additional morphine rescue to control the pain uses PCA appropriately and demonstrates no side effects Patients will have antiemetics and morphine loadingrescue dose 4mg Q15minute max 16mg per PACU nurse discretion per standard hospital protocol Patients will be continuously monitored overnight per nursing protocol and in addition to that with Remmers unit pulse oximetry respiratory effort respiratory flow airway pressure Pain score at rest and with cough and nauseavomiting will be assessed periodically and will be reported by patient in the postoperative diary Pain scores will be integrated separately over 24 hours to obtain area under curve at rest AUCr and with cough or activity AUCa Overnight oximetry recordings will be analyzed post hoc to determine RDI Patients with PCA will be monitored per hospital policy Q1h x 12h then Q2hx 12h All bariatric patients are continuously monitored overnight in the PACU or surgical step-down unit Nurses taking care of the patient routinely notify anesthesia andor surgical team about significant apneahypopnea
PCA usage log will be obtained from the pump and morphine given by the nurses will be added to calculate postoperative morphine cumulative dose for 24 hours If PCA is discontinued patient data will be analyzed as drop-off Per hospital PCA policy in the event of excessive sedation andor respiratory depression level of sedation 4 following actions are to be taken
STOP PCA PUMP stimulate patient support respirations with bag valve mask as needed
Have a coworker notify the Rapid Response Team Arrange for BMV O2 and suction
Hang Naloxone 08mg in 100ml 09 NS IVSS -continue until respirations are more than 9 bm or a total of 08mg is infused
Time 0 for the purposes of study will be time of admission to PACU PPT will be tested in the PACU in the subset of patients who are awake and wiling to perform QST testing when their pain is controlled with NRS4 QST will be repeated in qualifying patients awake pain controlled following day
In addition investigators will record
1 Transfusion requirement number of units
2 Difference between pre-operative and discharge hemoglobin
3 Requirement for surgical revision due to anastomotic leak
4 Incidence of wound infection
5 Readmission rate within 30 days
6 Preoperative and discharge GFR
7 Timed NRS-11 nurse recorded and VAS self reported for pain at rest and during cough or incentive spirometry
8 Area under the curve AUCr using NRS at rest and during incentive spirometrycough AUCa AUCr and AUCa will be separately integrated to area under curve for 24 hours
9 Total dose of morphine given by nurses for 24 hours
10 Morphine PCA usage hourly and cumulative24h
11 Presence of nauseavomiting for 24 hours
12 Antiemetic requirement number of doses
13 Time to oral tolerance clears solids hours
14 Time to bowel movement hours
15 Time patient meets discharge criteria from the PACU hours
16 Time to discharge from PACU hours
17 Time to discharge from hospital hours
18 Respiratory disturbance index baseline and postoperatively from Remmers unit
19 Incidence of desaturation to SpO295 90 and 80 baseline and postoperatively from Remmers unit Maximum FiO2 required postoperatively excluding first 2 hours immediately after surgery
20 Incidence of over sedation sedation score 3 and 4
21 Naloxone requirement if any
22 Patient satisfaction scores
23 Time to out of bed to chair hours
24 Time to stand-up hours
25 Time to ambulation hours
26 Time to baseline physical activity days
27 Max temperature
28 Incidence of DVT
29 Reason for delayed discharge 72 hours
30 Incidence of readmission within 4 weeks
31 Incidence of reoperation within 4 weeks
Data will be analyzed using commercially available statistical software
If dropouts to the study will be present intent to treat analysis will be performed
Metric scale data will be tested for normality of distribution Kolmogorov-Smirnov test Categorical data will be presented as absolute frequency and relative distribution For normally distributed data a t test for independent samples will be used to compare prepost differences between the treatment groups Otherwise a nonparametric Mann-Whitney test will be used Categorical data will be compared using chi square test or Fisher exact test for groups 5 Bonferonni correction will be done for multiple comparisons
After comparing groups for age sex BMI co morbidities surgical time baseline pressure pain thresholds investigators will investigate whether assignment into ibuprofen or saline groups makes a difference In the primary secondary and tertiary outcomes
Our null hypothesis H0 is that there will be no differences in cumulative 24h morphine consumption AUCa and AUCr for pain scores and that there will be no change in prepost difference in RDI and pressure pain thresholds In addition investigators hypothesize that there will be no difference in the incidence of nauseavomiting discharge readiness patient satisfaction among the test and control groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None