Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

Not Applicable

Completed

• Conditions: Regional Anesthesia Morbidity
• Interventions: Drug: FENT group; Drug: DEX group

• Registration Number: NCT06216197
• Lead Sponsor: Zulekha Hospitals

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).

Study Timeline

• Study Start: 2021-04-03
• Primary Completion: 2022-12-04
• Study Completion: 2022-12-04
• Study First Submitted: 2023-12-26
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
the duration until the first call for analgesia	20 months	the duration until the first call for analgesia

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Al-Azhar faculty of medicine; 🇪🇬 Cairo, Egypt