Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 ketamine's 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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | will include 30 patients, will receive intrathecal bupivacaine 10mg , ,2mg morphine. | |
| Ketamine group | Active Comparator | will include 30 patients, will receive intrathecal bupivacaine 10 mg , ,2 mg morphine, ,1 mg/kg ketamine . |
|
| Dexamethasone group | Active Comparator | will include 30 patients , will receive intrathecal bupivacaine 10 mg , ,2 mg morphine , intravenous dexamethasone 8mg . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | . Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and ,1 mg/kg ketamine added in group A under sterile condition |
| Measure | Description | Time Frame |
|---|---|---|
| first call for analgesia | The first call for analgesia (the elapsed time from the time of spinal anaesthesia until the first postoperative analgesic use after the end of the surgery, which will be administrated based on patient request). | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| nausea & vomiting | Incidence of Postoperative nausea & vomiting (PONV) 24 hours postoperatively. | 24 hours |
| analgesic requirement | The total analgesic requirement in 24 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| rokaya ma khalifa, resident | Contact | 01013940535 | Rokayakhalifa495@gmail.com | |
| mostafa sa abbas, dr | Contact | 01003060187 | mostafasamy@aun.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| nagwa mo ibraheem, prof | assuit study | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29210789 | Result | Gamez BH, Habib AS. Predicting Severity of Acute Pain After Cesarean Delivery: A Narrative Review. Anesth Analg. 2018 May;126(5):1606-1614. doi: 10.1213/ANE.0000000000002658. | |
| 33375192 | Result | Bornstein E, Husk G, Lenchner E, Grunebaum A, Gadomski T, Zottola C, Werner S, Hirsch JS, Chervenak FA. Implementation of a Standardized Post-Cesarean Delivery Order Set with Multimodal Combination Analgesia Reduces Inpatient Opioid Usage. J Clin Med. 2020 Dec 22;10(1):7. doi: 10.3390/jcm10010007. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| dexamethasone | Drug | . Standard monitoring procedures will include pulse oximetry, electrocardiography, and noninvasive arterial pressure prior to anesthetic induction. All patients will be premedicate antibiotic prophylaxis, according to the hospital's protocol. Anesthesia will be induced with intrathecal bupivacaine 10mg and iv dexamethasone will be added |
|
| 24 hours |
| 31058317 | Result | Heesen M, Rijs K, Hilber N, Eid K, Al-Oweidi A, Rossaint R, Klimek M. Effect of intravenous dexamethasone on postoperative pain after spinal anaesthesia - a systematic review with meta-analysis and trial sequential analysis. Anaesthesia. 2019 Aug;74(8):1047-1056. doi: 10.1111/anae.14666. Epub 2019 May 6. |
| 33962333 | Result | Sohnen S, Dowling O, Shore-Lesserson L. Single dose perioperative intrathecal ketamine as an adjuvant to intrathecal bupivacaine: A systematic review and meta-analysis of adult human randomized controlled trials. J Clin Anesth. 2021 Oct;73:110331. doi: 10.1016/j.jclinane.2021.110331. Epub 2021 May 5. |
| 6496899 | Result | Bion JF. Intrathecal ketamine for war surgery. A preliminary study under field conditions. Anaesthesia. 1984 Oct;39(10):1023-8. doi: 10.1111/j.1365-2044.1984.tb08895.x. |
| 29773484 | Result | Ituk U, Thenuwara K. The effect of a single intraoperative dose of intravenous dexamethasone 8 mg on post-cesarean delivery analgesia: a randomized controlled trial. Int J Obstet Anesth. 2018 Aug;35:57-63. doi: 10.1016/j.ijoa.2018.03.008. Epub 2018 Mar 26. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |