Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696678
Status:
WITHDRAWN
Last Update Posted:
2024-02-21
First Post:
2022-08-23
Brief Title:
Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery
Sponsor:
Ciusss de LEst de lÎle de Montréal
Organization:
Ciusss de LEst de lÎle de Montréal
Study Overview
Official Title:
Improving ObsQoR-11 With Continuous Wound Infusion Versus Intrathecal Morphine After Elective Cesarean Delivery A Randomized Double-Blinded Controlled Trial Targeting Patients Recovery and Satisfaction
Status:
WITHDRAWN
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The PI has permanently left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIVIMEC
Brief Summary:
The purpose of this prospective randomized double-blinded and controlled study is to evaluate the quality of recovery after elective cesarean delivery using the Obstetric Quality-of-Recovery-11 ObsQoR-11 score at 24 hours between patients receiving intrathecal morphine ITM group compared to patients receiving a ropivacaine continuous wound infusion CWI group
Detailed Description:
Background
Cesarean delivery CD is one of the most frequently practiced surgeries in the world Most anesthetic techniques include the use of intrathecal morphine for post-operative analgesia While it is the gold standard it still carries significant side effects Recently other analgesic options have been evaluated Continuous anesthetic wound infusion can provide satisfactory analgesia without intrathecal morphine administration Quality of recovery and patients satisfaction are patients-oriented outcomes which are now recommended as primary aim in clinical research However most of previous studies evaluating different post-operative analgesia management in cesarean delivery have focused primarily only on pain scores or opioid consumption which were not always clinically relevant even if some statistical difference was reported between groups A new scoring tool ObsQoR-11 have recently been validated for evaluating recovery after cesarean delivery The goal of the present study is to demonstrate an improvement in the quality of recovery after cesarean delivery as well as in patients satisfaction when ropivacaine continuous wound infusion is used compared to the standard management with intrathecal morphine
Hypothesis
The investigators hypothesized that the use of ropivacaine continuous wound infusion instead of intrathecal morphine for postoperative pain management will improve the ObsQoR-11 recovery score as well as patients satisfaction after elective cesarean delivery
Primary objective
To evaluate the ObsQoR-11 score at 24 hours between patients receiving intrathecal morphine ITM group compared to patients receiving a ropivacaine continuous wound infusion CWI group
Secondary objectives
1 To evaluate the global health score of the patient subpart of the ObsQoR-11 between ITM and CWI patients
2 To evaluate the quality of recovery after elective cesarean delivery using the ObsQoR-11 score at 48 and 72 hours between ITM and CWI patients
3 To evaluate the impact of the perioperative pain management on each item of ObsQoR-11 questionnaire including the quality of care the mother can provide to her child between ITM and CWI patients
4 To evaluate pain scores at rest at mobilization and the worst pain score as well as the opioid consumption morphine equivalent in the postanesthesia care unit PACU at 2 4 6 12 24 48 72 hours and 5 and 7 days after elective cesarean delivery between ITM and CWI patients
5 To evaluate the nausea and vomiting incidence and severity during the first 24 hours after elective cesarean delivery 2 4 6 12 and 24 hours between ITM and CWI patients
6 To evaluate the severity of the pruritus during the first 24 hours after elective cesarean delivery 2 4 6 12 and 24 hours between ITM and CWI patients
7 To evaluate the time to first mobilization with ambulation after elective cesarean delivery between ITM and CWI patients
Methods
Patients scheduled for an elective cesarean delivery performed under spinal anesthesia and meeting our inclusion criteria will be fully informed about the study protocol Interested patients will be invited to sign the informed consent form ICF Included patients will be invited to answer questionnaires to collect socio-demographic and medical history data eg comorbidities pregnancy details etc Patients will be randomized in one of two groups by a random computer-generated number using a 11 randomization ratio and variable random blocks of 4 and 6
Each patient will receive a prophylactic antacid medication consisting of 30 mL of sodium citrate 30 minutes before the surgery
Standard monitors will be placed on the patient including a continuous pulse oximeter continuous electrocardiography ECG and noninvasive blood pressure device taking blood pressure every 25 minutes Dräger Perseus A500 Drägerwerk AG Co KGaA Lübeck Germany
Induction and anesthesia maintenance
The anesthesia technique will be standardized Upon arrival in the OR spinal anesthesia will be performed in the sitting position at the lumbar level L2-L5 with a Whitacre needle 25 Gauge G BD Mississauga ON Canada
The control group ITM will receive a dose of 105 mg of bupivacaine 075 14 ml10 mcg of fentanyl 02 ml and 100 mcg of morphine 02 ml The patient will then be immediately placed in the supine position plus tilt to the left with a phenylephrine infusion running at 05 mcgkgmin lean body weight
The intervention group CWI will receive a dose of 105 mg of bupivacaine 075 14 ml 10 mcg of fentanyl 02 ml The patient will then be immediately placed in the supine position plus tilt to the left with a phenylephrine infusion running at 05 mcgkgmin lean body weight
Ten minutes after the spinal injection the sensory block will be evaluated to make sure it reaches a T4 level with the ice-test If the sensory blockade is unsatisfactory which means the spinal anesthesia will need to be complemented with intravenous analgesics or hypnotics then the patient will be withdrawn from the study
A 15 mcgkg-1 phenylephrine bolus lean body weight will be administered if the patient presents a hypotension or nauseavomiting episode
Hypotension will be defined as a decrease of the mean arterial blood pressure BP below 80 of normal baseline pre- spinal anesthesia injection values as measured before intrathecal injection for 2 consecutive BP values
If the hypotension persists a phenylephrine infusion will be titrated until BP reaches an adequate value If the mean arterial blood pressure increases above 120 of normal baseline values for 2 consecutive BP values the phenylephrine infusion will be diminished by steps of 02 mcgkgmin
If the heart rate decreases under 50 beatsminute while the arterial pressure remains normal a 02 mg IV glycopyrrolate bolus will be administered If the heart rate decreases under 50 beatsminute while the mean arterial pressure decreases under 80 of normal values a 5 mg IV ephedrine bolus will also be administered At any time during the surgery the anesthesiologist can derogate from this protocol if he deems that the security of the patient is at risk
Prophylactic antibiotics will be administered to each patient before the incision
Nausea and vomiting prophylaxis will consist of metoclopramide 10 mg IV after spinal anesthesia A rescue therapy of ondansetron 4 mg IV will be administered if the patient develops nausea or vomiting despite the prophylaxis
After umbilical cord clamping carbetocin 100 mcg IV will be administered
At the end of the surgery
In the control group ITM at wound closure a 19 Gauge 150 mm catheter InfiltraLong PAJUNK Medical System LP Norcross GA USA will be placed under the fascia and will be linked to an elastometric pump Baxter International Inc Deerfield IL USA filled with sterile saline 600 ml A bolus of 20 ml will be administered and an 8 mlh infusion based on previous published studies will be started Patients will also receive 100 mg of indomethacin and 1950 mg of acetaminophen per rectum PR at the end of the surgery before the transfer to PACU
In the intervention group CWI at wound closure a 19 Gauge 150 mm catheter InfiltraLong PAJUNK Medical System LP Norcross GA USA will be placed under the fascia and will be linked to an elastometric pump Baxter International Inc Deerfield IL USA filled with 02 ropivacaine 600 ml A bolus of 20 ml will be administered and an 8 mlh infusion will be started Patients will also receive 100 mg of indomethacin and 1950 mg of acetaminophen PR at the end of the surgery
The placement of the catheter in the fascial plane between the fascia of the transversalis muscle and the parietal peritoneum has been validated in previous studies
Management in postanesthesia care unit
After cesarean delivery the patient will be transported to the postanesthesia care unit PACU The patient will be discharged from PACU to the ward when specific criteria are achieved Bromage and Aldrete scores The arriving time at PACU will be T0 From T0 all criteria of the study will be evaluated as defined
Management in ward
For the management of post-operative pain all patients will benefit from the same protocol for the following 24 hours and after
They will receive acetaminophen 975 mg Per Oral PO every 6 hours regular and naproxen 500 mg PO Bis In Die BID regular for 72 hours
If the pain level is deemed at more than 310 on a Numeric Pain Rating NRS scale patients will be educated to request oxycodone 5 to 75 mg PO every 4 hours as needed If oxycodone is not enough or if the patient cannot tolerate medications by mouth morphine 5 to 75 mg subcutaneous SC every 4 hours will be administered as needed The doses of opioids needed as rescue therapy will be noted in the patients CRF All opioids consumed will be converted into equi-analgesic doses of PO morphine for analysis morphine 10 mg IV or SC hydromorphone 15 mg IV or SC oxycodone 20 mg PO
During the hospital stay if the patient feels nauseous enough to require medical treatment ondansetron 4 mg IV every 8 hours will be administered as needed If the nausea is persistent metoclopramide 10 mg IV every 4 hours will be given The dose may be repeated after 1 hour if the patient is still symptomatic For a maximum dosage of metoclopramide 20 mg every 4 hours In the event both medications fail to decrease the nausea dimenhydrinate 50 mg every 6 hours will be available as needed
If the patient experiences pruritus that is deemed severe enough to treat nalbuphine 25 mg SC every 4 hours will be administered If the patient is not relieved after an hour the medication will be repeated once for a maximum dosage of 5 mg SC every 4 hours If this medication is not enough after being reevaluated by the nursing team an hour later the patient will receive diphenhydramine 25 mg IV repeatable once for a maximum dosage of 50 mg IV every 4 hours
The patient will receive a visit from the research team or from the nursing staff at hours 2 4 6 12 and 24 after the cesarean delivery Every time the following elements will be noted in the patients case report form CRF
Pain scores at rest cough mobilization walking on a numerical rating scale 0 to 10
Pruritus level and incidence graded on a scale of 0 to 3 0 indicating no pruritus 1 indicating mild pruritus requiring no treatment 2 indicating moderate pruritus responsive to treatment and 3 indicating severe pruritus unresponsive to treatment
Nausea and vomiting level and incidence graded on a scale of 0 to 3 0 indicating no nausea or vomiting 1 indicating mild nausea requiring no treatment 2 indicating moderate nausea responsive to treatment and 3 indicating severe nausea unresponsive to treatment andor vomiting After 24 hours the following elements will also be assessed ObsQoR-11 questionnaire and score total PO morphine equivalent consumed number of medication administration required for pruritus number of medication administration required for nausea and time of the first mobilization
Same evaluations will be done at 48 and 72 hours The catheter will be removed under aseptic conditions at home at 72 hours by the patient after instructions given by the nursing staff
Cesarean delivery CD is one of the most frequently practiced surgeries in the world Most anesthetic techniques include the use of intrathecal morphine for post-operative analgesia While it is the gold standard it still carries significant side effects Recently other analgesic options have been evaluated Continuous anesthetic wound infusion can provide satisfactory analgesia without intrathecal morphine administration Quality of recovery and patients satisfaction are patients-oriented outcomes which are now recommended as primary aim in clinical research However most of previous studies evaluating different post-operative analgesia management in cesarean delivery have focused primarily only on pain scores or opioid consumption which were not always clinically relevant even if some statistical difference was reported between groups A new scoring tool ObsQoR-11 have recently been validated for evaluating recovery after cesarean delivery The goal of the present study is to demonstrate an improvement in the quality of recovery after cesarean delivery as well as in patients satisfaction when ropivacaine continuous wound infusion is used compared to the standard management with intrathecal morphine
Hypothesis
The investigators hypothesized that the use of ropivacaine continuous wound infusion instead of intrathecal morphine for postoperative pain management will improve the ObsQoR-11 recovery score as well as patients satisfaction after elective cesarean delivery
Primary objective
To evaluate the ObsQoR-11 score at 24 hours between patients receiving intrathecal morphine ITM group compared to patients receiving a ropivacaine continuous wound infusion CWI group
Secondary objectives
1 To evaluate the global health score of the patient subpart of the ObsQoR-11 between ITM and CWI patients
2 To evaluate the quality of recovery after elective cesarean delivery using the ObsQoR-11 score at 48 and 72 hours between ITM and CWI patients
3 To evaluate the impact of the perioperative pain management on each item of ObsQoR-11 questionnaire including the quality of care the mother can provide to her child between ITM and CWI patients
4 To evaluate pain scores at rest at mobilization and the worst pain score as well as the opioid consumption morphine equivalent in the postanesthesia care unit PACU at 2 4 6 12 24 48 72 hours and 5 and 7 days after elective cesarean delivery between ITM and CWI patients
5 To evaluate the nausea and vomiting incidence and severity during the first 24 hours after elective cesarean delivery 2 4 6 12 and 24 hours between ITM and CWI patients
6 To evaluate the severity of the pruritus during the first 24 hours after elective cesarean delivery 2 4 6 12 and 24 hours between ITM and CWI patients
7 To evaluate the time to first mobilization with ambulation after elective cesarean delivery between ITM and CWI patients
Methods
Patients scheduled for an elective cesarean delivery performed under spinal anesthesia and meeting our inclusion criteria will be fully informed about the study protocol Interested patients will be invited to sign the informed consent form ICF Included patients will be invited to answer questionnaires to collect socio-demographic and medical history data eg comorbidities pregnancy details etc Patients will be randomized in one of two groups by a random computer-generated number using a 11 randomization ratio and variable random blocks of 4 and 6
Each patient will receive a prophylactic antacid medication consisting of 30 mL of sodium citrate 30 minutes before the surgery
Standard monitors will be placed on the patient including a continuous pulse oximeter continuous electrocardiography ECG and noninvasive blood pressure device taking blood pressure every 25 minutes Dräger Perseus A500 Drägerwerk AG Co KGaA Lübeck Germany
Induction and anesthesia maintenance
The anesthesia technique will be standardized Upon arrival in the OR spinal anesthesia will be performed in the sitting position at the lumbar level L2-L5 with a Whitacre needle 25 Gauge G BD Mississauga ON Canada
The control group ITM will receive a dose of 105 mg of bupivacaine 075 14 ml10 mcg of fentanyl 02 ml and 100 mcg of morphine 02 ml The patient will then be immediately placed in the supine position plus tilt to the left with a phenylephrine infusion running at 05 mcgkgmin lean body weight
The intervention group CWI will receive a dose of 105 mg of bupivacaine 075 14 ml 10 mcg of fentanyl 02 ml The patient will then be immediately placed in the supine position plus tilt to the left with a phenylephrine infusion running at 05 mcgkgmin lean body weight
Ten minutes after the spinal injection the sensory block will be evaluated to make sure it reaches a T4 level with the ice-test If the sensory blockade is unsatisfactory which means the spinal anesthesia will need to be complemented with intravenous analgesics or hypnotics then the patient will be withdrawn from the study
A 15 mcgkg-1 phenylephrine bolus lean body weight will be administered if the patient presents a hypotension or nauseavomiting episode
Hypotension will be defined as a decrease of the mean arterial blood pressure BP below 80 of normal baseline pre- spinal anesthesia injection values as measured before intrathecal injection for 2 consecutive BP values
If the hypotension persists a phenylephrine infusion will be titrated until BP reaches an adequate value If the mean arterial blood pressure increases above 120 of normal baseline values for 2 consecutive BP values the phenylephrine infusion will be diminished by steps of 02 mcgkgmin
If the heart rate decreases under 50 beatsminute while the arterial pressure remains normal a 02 mg IV glycopyrrolate bolus will be administered If the heart rate decreases under 50 beatsminute while the mean arterial pressure decreases under 80 of normal values a 5 mg IV ephedrine bolus will also be administered At any time during the surgery the anesthesiologist can derogate from this protocol if he deems that the security of the patient is at risk
Prophylactic antibiotics will be administered to each patient before the incision
Nausea and vomiting prophylaxis will consist of metoclopramide 10 mg IV after spinal anesthesia A rescue therapy of ondansetron 4 mg IV will be administered if the patient develops nausea or vomiting despite the prophylaxis
After umbilical cord clamping carbetocin 100 mcg IV will be administered
At the end of the surgery
In the control group ITM at wound closure a 19 Gauge 150 mm catheter InfiltraLong PAJUNK Medical System LP Norcross GA USA will be placed under the fascia and will be linked to an elastometric pump Baxter International Inc Deerfield IL USA filled with sterile saline 600 ml A bolus of 20 ml will be administered and an 8 mlh infusion based on previous published studies will be started Patients will also receive 100 mg of indomethacin and 1950 mg of acetaminophen per rectum PR at the end of the surgery before the transfer to PACU
In the intervention group CWI at wound closure a 19 Gauge 150 mm catheter InfiltraLong PAJUNK Medical System LP Norcross GA USA will be placed under the fascia and will be linked to an elastometric pump Baxter International Inc Deerfield IL USA filled with 02 ropivacaine 600 ml A bolus of 20 ml will be administered and an 8 mlh infusion will be started Patients will also receive 100 mg of indomethacin and 1950 mg of acetaminophen PR at the end of the surgery
The placement of the catheter in the fascial plane between the fascia of the transversalis muscle and the parietal peritoneum has been validated in previous studies
Management in postanesthesia care unit
After cesarean delivery the patient will be transported to the postanesthesia care unit PACU The patient will be discharged from PACU to the ward when specific criteria are achieved Bromage and Aldrete scores The arriving time at PACU will be T0 From T0 all criteria of the study will be evaluated as defined
Management in ward
For the management of post-operative pain all patients will benefit from the same protocol for the following 24 hours and after
They will receive acetaminophen 975 mg Per Oral PO every 6 hours regular and naproxen 500 mg PO Bis In Die BID regular for 72 hours
If the pain level is deemed at more than 310 on a Numeric Pain Rating NRS scale patients will be educated to request oxycodone 5 to 75 mg PO every 4 hours as needed If oxycodone is not enough or if the patient cannot tolerate medications by mouth morphine 5 to 75 mg subcutaneous SC every 4 hours will be administered as needed The doses of opioids needed as rescue therapy will be noted in the patients CRF All opioids consumed will be converted into equi-analgesic doses of PO morphine for analysis morphine 10 mg IV or SC hydromorphone 15 mg IV or SC oxycodone 20 mg PO
During the hospital stay if the patient feels nauseous enough to require medical treatment ondansetron 4 mg IV every 8 hours will be administered as needed If the nausea is persistent metoclopramide 10 mg IV every 4 hours will be given The dose may be repeated after 1 hour if the patient is still symptomatic For a maximum dosage of metoclopramide 20 mg every 4 hours In the event both medications fail to decrease the nausea dimenhydrinate 50 mg every 6 hours will be available as needed
If the patient experiences pruritus that is deemed severe enough to treat nalbuphine 25 mg SC every 4 hours will be administered If the patient is not relieved after an hour the medication will be repeated once for a maximum dosage of 5 mg SC every 4 hours If this medication is not enough after being reevaluated by the nursing team an hour later the patient will receive diphenhydramine 25 mg IV repeatable once for a maximum dosage of 50 mg IV every 4 hours
The patient will receive a visit from the research team or from the nursing staff at hours 2 4 6 12 and 24 after the cesarean delivery Every time the following elements will be noted in the patients case report form CRF
Pain scores at rest cough mobilization walking on a numerical rating scale 0 to 10
Pruritus level and incidence graded on a scale of 0 to 3 0 indicating no pruritus 1 indicating mild pruritus requiring no treatment 2 indicating moderate pruritus responsive to treatment and 3 indicating severe pruritus unresponsive to treatment
Nausea and vomiting level and incidence graded on a scale of 0 to 3 0 indicating no nausea or vomiting 1 indicating mild nausea requiring no treatment 2 indicating moderate nausea responsive to treatment and 3 indicating severe nausea unresponsive to treatment andor vomiting After 24 hours the following elements will also be assessed ObsQoR-11 questionnaire and score total PO morphine equivalent consumed number of medication administration required for pruritus number of medication administration required for nausea and time of the first mobilization
Same evaluations will be done at 48 and 72 hours The catheter will be removed under aseptic conditions at home at 72 hours by the patient after instructions given by the nursing staff
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None