NCT05323214

Comparative Study Between Two Adjuvant Drugs to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

Comparative Study Between Dexmedetomidine and Fentanyl as Adjuvants to Bupivacaine for Post-operative Epidural Analgesia in Abdominal Surgeries

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Accepted

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

Conditions

• Epidural Analgesia

Interventions

Type	Name	Description
DRUG	Control Analgesic regimen	testing the efficiency of bupivacaine without adjuvant drugs in epidural analgesia
DRUG	Fentanyl Analgesic regimen	testing the efficiency of Fentanyl as an adjuvant drug to bupivacaine in epidural analgesia
DRUG	Dexmedetomidine Analgesic regimen	testing the efficiency of Dexmedetomidine as an adjuvant drug to bupivacaine in epidural analgesia

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-08-31
• Completion: 2022-09-30
• First posted: 2022-04-12
• Last updated: 2022-07-15

Locations

1 site across 1 country: Egypt