Regional Anesthesia Morbidity
Conditions
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).
Interventions
DRUGFENT group
Group FENT, consisting of 29 patients, underwent a saddle block with hyperbaric bupivacaine (2.5 ml) combined with fentanyl (0.5 ml; 25 μg).
DRUGDEX group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).
Sponsors
Zulekha Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Masking description
The subjects were randomly categorized into two groups utilizing random numbers generated by computer software. A sealed envelope (containing the allocation numbers of groups) was opened at the time of patient enrollment.
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).
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the duration until the first call for analgesia | 20 months | the duration until the first call for analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the duration from spinal injection until reaching the maximal sensory level | 20 months | the duration from spinal injection until reaching the maximal sensory level |
| the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level | 20 months | the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level |
| the time required for sensory regression until reaching the S1 level (from the maximal sensory level) | 20 months | the time required for sensory regression until reaching the S1 level (from the maximal sensory level) |
| the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours) | 20 months | the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours) |
| side effects occurrences | 20 months | side effects occurrences |
Countries
Egypt
Outcome results
None listed