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Phase 3 N=35 Treatment

Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block

Perianal Surgery

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Minimal Effective Dose of Hyperbaric Bupivacaine — 1.9 milligrams

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Dixon's up-and-down method (Drug)
Age
Adult · 20+ yrs
Sex
All
Sponsor
Imam Abdulrahman Bin Faisal University
Primary completion
Sep 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Minimal Effective Dose of Hyperbaric Bupivacaine
1.9
SECONDARY
Sacral Level of Sensory Block
4; 4; 4
SECONDARY
Motor Block Score as Assessed Using the Bromage Scale
0; 0
SECONDARY
Patient's Satisfactions
3
SECONDARY
Surgeon's Satisfactions
3

Summary

The optimal anesthetic technique would provide excellent operating conditions, rapid recovery, early discharge, no postoperative side effects, and high patient's satisfaction. In addition to increasing the quality and decreasing the costs of the anesthetic services (1). Selective spinal anesthesia (SSA) -spinal block with minimal effective doses for a specific type of surgery - has become very popular technique) 2(for some orthopedic and gynecological surgeries [3-9]. Saddle anesthesia is a SSA directs a small bolus of hyperbaric local anesthetic, towards S4-S5 and coccygeal nerve roots (11), and is commonly utilized for perianal surgeries (11-14). Hyperbaric bupivacaine has been safely, replaced hyperbaric Lidocaine for saddle block (11, 12). Although Saddle blocks at different low doses of hyperbaric bupivacaine (1.5- 4 mg) have been used previously for mi¬nor perianal surgeries (11, 13, 14), the optimal effective dose has yet to be determined. The objective of this study is to determine the minimal effective dose of hyperbaric spinal bupivacaine required to induce a reliable and satisfactory saddle block for perianal surgeries (using a modified Dixon's up-and-down method.

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists physical Status I and II patients.
  • Scheduled for outpatient elective perianal surgery.

Exclusion Criteria

  • Patients unwilling to participate.
  • Contraindications to regional anesthesia.
  • Morbid obesity.
  • Bleeding disorders.
  • Mental health problems.
  • Language barrier.
  • Taking psychotropic or analgesic medication.
  • History of allergic reactions to amide local anesthetics.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02299167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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