Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block (saddle)

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

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

Study Overview

• Status: Completed
• Conditions: Regional Anesthesia Morbidity
• Intervention / Treatment: Drug: FENT group; Drug: DEX group

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12546
    • Al-Azhar Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: The 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).	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).; Other Names: fentanyl group
Other: The DEX Group; The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).	Drug: DEX group; The DEX Group, consisting of 29 patients, received 2.5 ml of hyperbaric bupivacaine mixed with dexmedetomidine (10 μg; 0.5 ml).; Other Names: dexmedetomidine group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration until the first call for analgesia	the duration until the first call for analgesia	20 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration from spinal injection until reaching the maximal sensory level	the duration from spinal injection until reaching the maximal sensory level	20 months
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
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
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
side effects occurrences	side effects occurrences	20 months

Collaborators and Investigators

• Sponsor: Zulekha Hospitals
• Investigators: Study Chair: sameh ha seyam, MD, assistant professor of anesthesiology, intensive care and pain management

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2021
• Primary Completion (Actual): December 4, 2022
• Study Completion (Actual): December 4, 2022

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 10, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: 0395/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No