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Epidural analgesia is associated with early postoperative mobilization and rehabilitation with minimally associated pain and discomfort. Analgesic effect of local anesthetics is augmented by addition of adjuvants in epidural anesthesia ensuring satisfactory postoperative period. This study evaluates the effect of dexmedetomidine and fentanyl as additives to bupivacaine for epidural analgesia.
The aim of the study is to evaluate the effect of dexmedetomidin and fentanyl as adjuvants to bupivacaine for postoperative epidural analgesia in abdominal surgeries regarding block characteristics, post-operative analgesia, hemodynamic changes and any anticipated side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Other | Normal saline 2 ml will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours. |
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| Fentanyl group | Other | Fentanyl 2 ml (100 μg) will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours. |
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| Dexmedetomidine group | Other | Dexmedetomidine 1 ml (100 μg) plus 1 ml normal saline will be mixed with 48 ml bupivacaine 0.125% in an elastomeric pump. The rate of epidural infusion will be 5ml/hr for the postoperative 24 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Analgesic regimen | Drug | testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory analgesia | will be assessed by pin prick and cold application from the start of epidural infusion till scoring 1 at the 3 point scale. Assessment will be done every 5 minutes until the onset of sensory block using a 3-point scale: 0=normal sensation, 1=loss of sensation of pin prick (analgesia), and 2=loss of sensation of touch (anesthesia). | 24 hours |
| Duration of analgesia | time from starting epidural infusion to the time of the first request for additional pain medication | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain score | for 24 hours using the Visual Analogue Scale ranging from 0 to 10 (0 - no pain, 10 - worst pain ever) at 0, 2, 6, 12 and 24 hrs after starting epidural infusion. | 24 hours |
| Analgesic consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim A Ibrahim, MD | Contact | +201208208230 | Drhema2010n@gmail.com | |
| Mohamed A Saleh, MD | Contact | +201092847049 | senomola@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Bahaa Eldin E Hassan, Professor | Department of Anesthesia, Intensive care and pain management, Ain Shams University. | Study Chair |
| Hadeel M Abd Elhamid, Professor | Department of Anesthesia, Intensive care and pain management, Ain Shams University. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospitals | Recruiting | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21897496 | Background | Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available. | |
| 30464585 | Background | Hetta DF, Fares KM, Abedalmohsen AM, Abdel-Wahab AH, Elfadl GMA, Ali WN. Epidural dexmedetomidine infusion for perioperative analgesia in patients undergoing abdominal cancer surgery: randomized trial. J Pain Res. 2018 Oct 30;11:2675-2685. doi: 10.2147/JPR.S163975. eCollection 2018. |
| Label | URL |
|---|---|
| National institute for health and clinical excellence | View source |
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| Fentanyl Analgesic regimen | Drug | testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia |
|
|
| Dexmedetomidine Analgesic regimen | Drug | testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia |
|
|
during the 24 hours following epidural infusion.
| 24 hours |
| The motor block | will be assessed if occurred by Bromage three point score (0-3) for the lower extremity during the 24 hours following epidural infusion where 0: no motor impairment (able to move the hip, knee, and ankle joints);
| 24 hours |
| Post operative Mean arterial Blood pressure | Mean arterial pressure in mmHg will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion | 24 hours |
| Post operative Heart rate | Heart rate (HR) in beats per minute (bpm) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion | 24 hours |
| Post operative Peripheral oxygen saturation | Peripheral oxygen saturation in blood (SpO2) will be monitored continuously and recorded just before the initiation of epidural infusion and thereafter at 2, 6, 12 and 24 hrs. postoperatively during the 24 hours following epidural infusion | 24 hours |
| Anticipated adverse events | like postoperative nausea and vomiting during the 24 hours from the start of epidural analgesia | 24 hours |
| Mohamed A Saleh, MD | Department of Anesthesia, Intensive care and pain management, Ain Shams University. | Study Director |
| Ibrahim A Ibrahim, MD | Department of Anesthesia, Intensive care and pain management, Ain Shams University. | Study Director |
| 29643621 | Background | Kiran S, Jinjil K, Tandon U, Kar S. Evaluation of dexmedetomidine and fentanyl as additives to ropivacaine for epidural anesthesia and postoperative analgesia. J Anaesthesiol Clin Pharmacol. 2018 Jan-Mar;34(1):41-45. doi: 10.4103/joacp.JOACP_205_16. |
| 28442930 | Background | Mohamad MF, Mohammad MA, Hetta DF, Ahmed EH, Obiedallah AA, Elzohry AAM. Thoracic epidural analgesia reduces myocardial injury in ischemic patients undergoing major abdominal cancer surgery. J Pain Res. 2017 Apr 12;10:887-895. doi: 10.2147/JPR.S122918. eCollection 2017. |
| 26006222 | Background | Yousef AA, Salem HA, Moustafa MZ. Effect of mini-dose epidural dexmedetomidine in elective cesarean section using combined spinal-epidural anesthesia: a randomized double-blinded controlled study. J Anesth. 2015 Oct;29(5):708-14. doi: 10.1007/s00540-015-2027-7. Epub 2015 May 26. |
| 27513640 | Background | Zhao Y, Xin Y, Liu Y, Yi X, Liu Y. Effect of Epidural Dexmedetomidine Combined With Ropivacaine in Labor Analgesia: A Randomized Double-Blinded Controlled Study. Clin J Pain. 2017 Apr;33(4):319-324. doi: 10.1097/AJP.0000000000000411. |
| Background | Soliman, Rabie & Eltaweel, Moataz. (2016). Comparative study of dexmedetomidine and fentanyl as an adjuvant to epidural bupivacaine for postoperative pain relief in adult patients undergoing total knee replacement: a randomized study. Journal of Anesthesiology and Clinical Science. 5. 1. 10.7243/2049-9752-5-1. |