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Not yet recruiting NCT07114263

Study of The Analgesic Profile of Two Adjuvants Added to Low Dose Hyperbaric Bupivacaine Versus One Adjuvant in Patients Undergoing Anal Surgery Using Spinal Anesthesia

No phase Interventional Spinal Anesthesia Administration Analgesic Anorectal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group F (fentanyl group), Group D :Dexmedetomidine group, Group DF :Fentanyl and Dexmedetomidine group.
Who it may be relevant to
Registry conditions: Spinal Anesthesia Administration, Analgesic, Anorectal Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Study of The Analgesic Profile of Two Adjuvants Added to Low Dose Hyperbaric Bupivacaine Versus One Adjuvant in Patients Undergoing Anal Surgery Using Spinal Anesthesia ( Saddle Block ): A Randomized Prospective Study

Overview

This study will be conducted to compare the efficacy of fentanyl and Dexmedetomidine as an additive to hyperbaric bupivacaine 0.5% in saddle block anesthesia on duration of analgesia in patients undergoing anorectal surgeries.

Detailed description

Pilonidal sinus, hemorrhoidectomy, anal fistula or fissure repair are the main types of anorectal surgery. Various surgical and anesthetic techniques have been introduced to improve analgesia level and limit the motor blockade.Regional anesthesia is preferred for anorectal surgeries to avoid the risks of general anesthesia. Besides, providing effective post-operative analgesia, regional techniques reduce the opioid use.

Intrathecal administration of drugs to obtain anesthesia has been in use since the turn of the twelfth century. Saddle block anesthesia is a kind of low spinal block that provides anesthesia over the saddle area, i.e., perineum, perianal area, medial aspect of legs and thigh.

Saddle block anesthesia is performed by injecting a small dose of hyperbaric local anaesthetic at the level of L3, L4 after which the patient is maintained in sitting position for a few minutes to facilitate preferential impregnation of sacred roots (S1 to S5), which is responsible for innervation of perineum, external genitalia and anus. The saddle block causes a parasympathetic blockade at the bladder level which may result in bladder and rectal atony which is advantageous because of sphincteric relaxation needed for the operation.

Hyperbaric bupivacaine 0.5% is the most common local anaesthetic used for spinal anaesthesia for lower abdominal and lower limb surgeries. One disadvantage with using hyperbaric bupivacaine alone is a relatively shorter duration of action that means that early analgesic intervention is needed in postoperative period. Adjuvants are drugs that increase the efficacy or potency of other drugs when given concurrently. Neuraxial adjuvants are used to increase the speed of the onset of neural blockade (reduce latency), improve the quality and prolong the duration of neural blockade.

Fentanyl is a lipophilic short-acting opioid that exhibits close structural similarities to local anesthesia and has demonstrable local anesthetic efficacy on sensory C primary afferent nerve fibers, which may facilitate analgesic effects. It has improved spinal anesthesia and reduced the anesthetic drug related side effects including pruritus, nausea and vomiting.

Dexmedetomidine, a highly selective alpha\_2 agonist, is being introduced as an adjuvant to local anesthetics with significant analgesic, sympatholytic, and sedative properties. Compared to clonidine; Dexmedetomidine is approximately eight times more selective towards α2-adrenergic receptors , which is associated with sedative and analgesic effects in supraspinal and spinal sites and also has an antinociceptive impact on both visceral and somatic pain.

This study will be conducted to compare the efficacy of fentanyl and Dexmedetomidine as an additive to hyperbaric bupivacaine 0.5% in saddle block anesthesia on duration of analgesia in patients undergoing anorectal surgeries.

Interventions

  • Drug Group F (fentanyl group)
    Group F (fentanyl group):will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5% and 0.5 ml (25 mcg) Fentanyl and 1 ml glucose 5% with total volume of 3ml.
  • Drug Group D :Dexmedetomidine group
    Group D :Dexmedetomidine group: will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5% and 1 ml (4 mcg) Dexmedetomidine and 0.5 ml glucose 5% with total volume of 3ml.
  • Drug Group DF :Fentanyl and Dexmedetomidine group
    Fentanyl and Dexmedetomidine group:will receive intrathecal 1.5 ml hyperbaric bupivacaine 0.5%, 0.5 ml (25 mcg) Fentanyl and 1 ml (4 mcg) Dexmedetomidine with total volume of 3ml.

Primary outcome measures

  • Duration of analgesia [Time frame: 2 hours]
Secondary outcome measures (1)
  • Incidence of complications [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • aged from 18 to 65 years
  • American Society of Anesthesiologists' physical I or II of both sexes
  • Patients who will be scheduled to surgery for their uncomplicated hemorrhoids, anal fissure, or anal fistula in lithotomy position will be included in the study.

Exclusion criteria

  • Infection focus at back, history of spine surgery, coagulopathy, mental disturbance, and neurological disease.
  • drug allergy.
  • intake of experimental or analgesic medication within last 24 hours.
  • patients receiving alpha-adrenergic antagonist will be excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Egypt · 1 center
  • Tanta University — Tanta

Identifiers

NCT: NCT07114263 · 36264MS785/12/24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗