Clinical trial NCT05323214: Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
Official title: Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Epidural Analgesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 75
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

* Type of Study: Prospective randomized comparative clinical study.
* Study Setting: The operating theatres of Ain Shams University Hospitals
* Study Period: One year
* Sampling Method: Random sampling Patients randomly allocated by computer generated randomization and using opaque sealed envelopes to one of the three study groups according to the adjuvant drug used in postoperative analgesia.
* Sample Size: Total 75 cases divided into 25 cases in each group. Kiran et al. (2018) reported a rather large effect size comparing onset to sensory block and time to maximum motor block. In a one-way ANOVA study, sample sizes of 25 cases per group in three groups whose means are to be compared. The total sample of 75 subjects achieves 80% power to detect differences among the means versus the alternative of equal means using an F test with a 0.0500 significance level. The size of the variation in the means is represented by the effect size = 0.4

Eligibility criteria: Inclusion Criteria:

* ASA I or ASA II patients.
* Age group: 21-70 years old.
* BMI ≤40
* Duration of procedure ≤ 180 minutes.

Exclusion Criteria:

* Patients with known neurologic and psychiatric illness will be excluded from the study.
* Contraindications for epidural anesthesia as patient refusal, bleeding or coagulation test abnormalities, local skin infection at spinal lumbar region, raised intracranial pressure and hypovolemia
* Spine abnormalities.
* Systemic disorders like hematological, respiratory, cardiac, renal or hepatic insufficiency.
* Allergy to any of the drugs used in the study.

Primary outcomes:
measure: Onset of sensory analgesia
timeFrame: 24 hours
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative pain score
timeFrame: 24 hours
measure: Analgesic consumption
timeFrame: 24 hours
measure: The motor block
timeFrame: 24 hours
measure: Post operative Mean arterial Blood pressure
timeFrame: 24 hours
measure: Post operative Heart rate
timeFrame: 24 hours
measure: Post operative Peripheral oxygen saturation
timeFrame: 24 hours
measure: Anticipated adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Bahaa Eldin E Hassan, Professor
role: STUDY_CHAIR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Hadeel M Abd Elhamid, Professor
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Mohamed A Saleh, MD
role: STUDY_DIRECTOR
affiliation: Department of Anesthesia, Intensive care and pain management, Ain Shams University.
name: Ibrahim A Ibrahim, MD
role: STUDY_DIRECTOR
References:
citation: Grewal A. Dexmedetomidine: New avenues. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):297-302. doi: 10.4103/0970-9185.83670. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.