Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

Regional Anesthesia Morbidity Clinical Trial

— saddle  

Official title:

Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block for Various Anal Surgeries: A Correlative Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06216197
• Other study ID #: 0395/2023
• Status: Completed
• Phase: N/A
• Start date: April 3, 2021
• Est. completion date: December 4, 2022

Study information

• Verified date: January 2024
• Source: Zulekha Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 4, 2022
• Est. primary completion date: December 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Regional Anesthesia Morbidity

Intervention

Drug:
• FENT 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).
• DEX group
The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 µg; 0.5 ml).

Locations

Country	Name	City	State
Egypt	Al-Azhar faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Zulekha Hospitals

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the duration until the first call for analgesia	the duration until the first call for analgesia	20 months
Secondary	the duration from spinal injection until reaching the maximal sensory level	the duration from spinal injection until reaching the maximal sensory level	20 months
Secondary	the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level	the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level	20 months
Secondary	the time required for sensory regression until reaching the S1 level (from the maximal sensory level)	the time required for sensory regression until reaching the S1 level (from the maximal sensory level)	20 months
Secondary	the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)	the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)	20 months
Secondary	side effects occurrences	side effects occurrences	20 months