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Completed

NCT Number: NCT06216197

Dexmedetomidine Versus Fentanyl as an Adjuvant to Bupivacaine in Saddle Block

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

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Key information

Conditions

Regional Anesthesia Morbidity

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar faculty of medicine

Cairo, 12546, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

FENT group

Drug

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

DEX group

Drug

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

Primary outcomes

  1. the duration until the first call for analgesia

    Time frame: 20 months

    the duration until the first call for analgesia

Secondary outcomes

  1. the duration from spinal injection until reaching the maximal sensory level

    Time frame: 20 months

    the duration from spinal injection until reaching the maximal sensory level

  2. the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level

    Time frame: 20 months

    the duration needed for sensory regression to occur over two spinal segments from the maximal sensory level

  3. the time required for sensory regression until reaching the S1 level (from the maximal sensory level)

    Time frame: 20 months

    the time required for sensory regression until reaching the S1 level (from the maximal sensory level)

  4. the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)

    Time frame: 20 months

    the duration from injection to achieving Bromage 0, the total tramadol consumption (until the first 24 hours)

  5. side effects occurrences

    Time frame: 20 months

    side effects occurrences

Sponsors and collaborators

Lead sponsor

Zulekha Hospitals

Other

Registry information

Official study title

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

Acronym: saddle

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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