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

Ain Shams University

Status and phase: Enrolling; Phase 4

Conditions: Epidural Analgesia

Treatments: Drug: Control Analgesic regimen; Drug: Fentanyl Analgesic regimen; Drug: Dexmedetomidine Analgesic regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT05323214

FMASU MD 121/2021

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: All

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 3 patient groups

Control group

Other group

Description:

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.

Treatment:

Drug: Control Analgesic regimen

Fentanyl group

Other group

Description:

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.

Treatment:

Drug: Fentanyl Analgesic regimen

Dexmedetomidine group

Other group

Description:

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.

Treatment:

Drug: Dexmedetomidine Analgesic regimen