Clinical trial NCT06216197: Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block
Official title: Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Zulekha Hospitals
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Primary purpose: SCREENING

Brief summary: Dexmedetomidine is recommended over fentanyl as adjunctive medication to bupivacaine for saddle block spinal anesthesia in anal surgeries and procedures.

Detailed description: Objectives: A saddle spinal block is a viable choice for anal surgeries. This technique effectively maintains balanced hemodynamics, and fast recovery, and prevents irrelevant motor blocks in both limbs.

Methods: Fifty-eight adult patients were categorized into two groups. Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg). The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml). Continuous monitoring of HR and SpO2 was conducted. Evaluation of sensory blockage and the motor block was done utilizing the Bromage scale. Following surgery, assessments were conducted. Pain in the ward and PACU was determined utilizing the visual analog scale (VAS).

Eligibility criteria: Inclusion Criteria:

* both sexes
* aged between 20 and 60
* classified as II \& ASA-I
* scheduled for elective anal surgeries

Exclusion Criteria:

* subjects who refused to participate
* uncontrolled hypertension
* BMI \> 30 kg/m2
* heart failure (class IV or III) based on the New York Heart Association (NYHA)
* uncorrected coagulopathy
* any study's drug allergy
* drug abuse
* neuropathy
* any spinal anesthesia contraindication (such as infection or a pelvic fracture)

Primary outcomes:
measure: the duration until the first call for analgesia
timeFrame: 20 months
Secondary outcomes:
measure: the duration from spinal injection until reaching the maximal sensory level
timeFrame: 20 months
measure: the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level
timeFrame: 20 months
measure: the time required for sensory regression until reaching the S1 level (from the maximal sensory level)
timeFrame: 20 months
measure: the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)
timeFrame: 20 months
measure: side effects occurrences
timeFrame: 20 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Azhar faculty of medicine
Study officials:
affiliation: assistant professor of anesthesiology, intensive care and pain management
name: sameh ha seyam, MD
role: STUDY_CHAIR
References: