Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block

NCT02299167 | Completed Phase 3 Results DMC

• 1 other identifier: ANE-2014-1-23
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Perianal Surgery

Keywords

Perianal surgery; hyperbaric bupivacaine; saddle block

Outcome Measures

Primary Outcomes (1)

• Minimal Effective Dose of Hyperbaric Bupivacaine

  the minimal effective dose of hyperbaric bupivacaine using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.

  10 min after dural puncture

Secondary Outcomes (4)

• Sacral Level of Sensory Block

  every 30 min until complete regression of the block (approximately 90 min)

• Motor Block Score as Assessed Using the Bromage Scale

  every 30 min until Time to ambulation (approximately 2 hours)

• Patient's Satisfactions

  24 hours after surgery

• Surgeon's Satisfactions

  24 hours after procedure

Study Arms (1)

Saddle block

EXPERIMENTAL

The dose of bupivacaine given to each patient was determined by the response of the previously tested patient using a modified Dixon's up-and-down method

Drug: Dixon's up-and-down method

Interventions

Dixon's up-and-down method DRUG

using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.

Saddle block

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead

Results Point of Contact

• Title: Roshdi R. Al-Metwalli
• Organization: Dammam University

rmetwalli@iau.edu.sa

+966 50 289 3485

Study Officials

• Roshdi Al Metwalli, MD

  Associate Professor at Anesthesiology Dept

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 24, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: November 24, 2020
• Results First Posted: November 24, 2020

Record last verified: 2020-09