Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408974
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2023-11-27
Brief Title:
Comparison Between Ketamine Intrathecal and iv Dexamethasone for Post Cesarean Analgesia
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
A Comparison Of Intrathecal Ketamine Versus Intravenous Dexamethasone For Postoperative Analgesia In Parturients Undergoing Spinal Anaesthesia For Cesarean Section A Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The aim of our study is to compare the postoperative analgesic efficacy of intrathecal ketamine added to bupivacaine to that of intravenous dexamethasone in patients undergoing cesarean section under bupivacaine spinal anesthesia
Detailed Description:
Caesarean delivery is associated with postoperative pain that may influence recovery psychological maternal well-being and breastfeeding Multimodal analgesic regimen including an intrathecal long-acting opioid non-steroidal anti-inflammatory drugs and acetaminophen has been suggested to effectively control postoperative pain after caesarean delivery Intravenous dexamethasone is recommended in elective caesarean delivery to decrease postoperative pain Several systematic reviews and meta-analyses have examined the efficacy of dexamethasone after caesarean delivery and reported decreased postoperative pain and prolonged time to first analgesia In the same context a meta-analysis of randomized controlled trials in humans suggests that there may be a benefit to using intrathecal ketamine as an adjunct to bupivacaine to improve postoperative pain after cesarean section The mechanisms of action of intrathecal ketamine are incompletely understood One study reports that ketamines high lipophilicity allows for rapid diffusion into the venous system namely through the azygos vein
The following parameters will be monitored intraoperatively every 5 min
HR SBP DBP and MAP and SpO2 and documented every 15 min till the end of surgery
Any hemodynamic response to skin incision and to subsequent surgical steps will be documented
For maintaining HR or systolic in range of more or less than 20 of baseline intraoperatively ephedrine and intravenous fluids will be used No other analgesic will be given intraoperatively
primperan 01 mgkg will be given at the end of the procedure to all patients
All patients will receive 20 iu of oxytocin more till 40 iu or any ueterotonic drugs papalmethylergometrine if needed
Postoperative pain will be assessed using an 11-point 0no pain and 10worst pain numeric rating scale NRS NRS for pain at rest and when coughing will be assessed serially at 1 2 4 8 16 and 24 h after surgery The assessor and the patients will be unaware of the type of intervention received
Time for first analgesic request and NRS at first analgesic request will be recorded The duration of analgesia will be evaluated as the time from block administration to the time at which patient complained of pain or NRS 4 on assessment at serial intervals and nalurphine will be used as rescue analgesia Total doses of analgesics required in the first 24 h will be recorded
The presence of postoperative nausea and vomiting during the first 24 h will be recorded Postoperative nausea or vomiting will be treated with 01 mgkg of ondansetron If the patient did not respond to ondansetron then metoclopramide 10 mg will be given IV Occurrence of any complications such as sedation nystagmus dizziness will be assessed
The following parameters will be monitored intraoperatively every 5 min
HR SBP DBP and MAP and SpO2 and documented every 15 min till the end of surgery
Any hemodynamic response to skin incision and to subsequent surgical steps will be documented
For maintaining HR or systolic in range of more or less than 20 of baseline intraoperatively ephedrine and intravenous fluids will be used No other analgesic will be given intraoperatively
primperan 01 mgkg will be given at the end of the procedure to all patients
All patients will receive 20 iu of oxytocin more till 40 iu or any ueterotonic drugs papalmethylergometrine if needed
Postoperative pain will be assessed using an 11-point 0no pain and 10worst pain numeric rating scale NRS NRS for pain at rest and when coughing will be assessed serially at 1 2 4 8 16 and 24 h after surgery The assessor and the patients will be unaware of the type of intervention received
Time for first analgesic request and NRS at first analgesic request will be recorded The duration of analgesia will be evaluated as the time from block administration to the time at which patient complained of pain or NRS 4 on assessment at serial intervals and nalurphine will be used as rescue analgesia Total doses of analgesics required in the first 24 h will be recorded
The presence of postoperative nausea and vomiting during the first 24 h will be recorded Postoperative nausea or vomiting will be treated with 01 mgkg of ondansetron If the patient did not respond to ondansetron then metoclopramide 10 mg will be given IV Occurrence of any complications such as sedation nystagmus dizziness will be assessed
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