A Phase 2/3 interventional study of TEA+DEX and TEA in Abdominal Pain and Abdominal Cancer, sponsored by South Egypt Cancer Institute. Completed at 1 site in Egypt. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by South Egypt Cancer Institute · Phase 2/3, Interventional, and Prevention
Dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.
The aim of modern anaesthetic practice is to insure the rapid recovery of patients with fewer complications and earlier hospital discharge.
Thoracic epidural anesthesia (TEA) has been established as a cornerstone in the perioperative care after thoracic and major abdominal surgery providing most effective analgesia. beyond its analgesic properties, TEA's effects on the postoperative neurohumoural stress response, cardiovascular Pathophysiology, and intestinal dysfunction have been in the focus of both clinical and experimental investigations for years.
dexmedetomidine if add to patient controlled epidural analgesia for patients undergoing major abdominal cancer surgery may improve its effects.
Exclusion Criteria:
Intra operative thoracic epidural injection of (bupivacaine 0.125% +fentanyl 2 mic/ ml) , initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till end of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml + dexmedetomidine 0.5 mic/ ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min
Procedure: TEA+DEX
Intraoperative,thoracic epidural injection of bupivacaine (0.125%+fentanyl 5 mic/ml ) ,initial bolus dose of 8 ml before skin incision followed by fixed rate infusion of 6 ml/h till start of abdominal layer closure. Postoperative, thoracic epidural injection of (bupivacaine 0.0625%+fentanyl 2 mic /ml) at infusion rate 6 ml /h and bolus dose of 3 ml with lockout time 10 min
Procedure: TEA
intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.
Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline. then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml.
Change in pain scores (dynamic VAS)
dynamic visual analogue scale (0-10) 0=no pain 10=worst imaginable pain
Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Change in post operative MAP
Mean arterial pressure
Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Plan to share: No
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South Egypt Cancer Institute