Phase 3
N=35
Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block
Perianal Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02299167 ↗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
| Outcome | Result | p-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.
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.