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Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block

The Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Successful Reliable Saddle Block for Minor Perianal Surgeries

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02299167
Enrollment
35
Registered
2014-11-24
Start date
2014-01-31
Completion date
2014-10-31
Last updated
2020-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perianal Surgery

Keywords

Perianal surgery, hyperbaric bupivacaine, saddle block

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.

Detailed description

Following approval of the Research and Ethics Committee of the University of Dammam and written informed consent, patients with American Society of Anesthesiologists physical Status I and II, aged 20-55 years, scheduled for outpatient elective perianal surgery in the lithotomy position ( hemorrhoidectomy, fistulectomy), were prospectively enrolled in this study. Patients unwilling to participate, those with contraindications to regional anesthesia, morbid obesity, bleeding disorders, mental health problems or language barriers, taking psychotropic or analgesic medication, or a known history of allergic reactions to amide local anesthetics, were excluded from the study. Actually, 35 patients were enrolled. However; after they have signed the informed consent; 7 patients were excluded because they have received analgesics in the morning of surgery, and 4 patients refused to receive the saddle block on the operating room. So actually 24 patients out of 35 participants underwent intervention All patients were fasted for over 6 hours and were premedicated with 0.2 mg/kg oral diazepam 60 min before spinal anesthesia. In the operating room (OR), an intravenous (IV) 18-20G catheter was placed, and standard monitoring \[electrocardiogram (ECG), heart rate (HR), oxygen saturation (SpO2), and noninvasive blood pressure (NIBP)\] were started. Under aseptic conditions, the dural puncture was performed by staff-grade anesthesiologists, using a standard midline approach in the sitting position at the L3-L4 or L4-L5 intervertebral space, using a 25-gauge Whitacre needle with its orifice directed caudally. A predetermined small dose of hyperbaric bupivacaine (Marcaine Spinal Heavy; Astra Zeneca, Lund, Sweden) which was prepared in1 mL tuberculin syringe was injected. All patients remained in the sitting position for 10 min. the patient was asked if he/she perceived any change in motor power. If not, the patient was allowed to position him/herself without aid for surgery in the lithotomy position. Immediately before surgery, the sacral level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions. The motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block). A successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia). 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 (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if the patient responded with a failed block then the next patient received an increment of 0.5 mg bupivacaine, if the patient responded with a successful block, then the next patient received a decrement of 0.5 mg bupivacaine. The research continued until the investigators obtained seven crossover midpoints. The initial starting dose of 1.5 mg hyperbaric bupivacaine of the first patient was selected from the findings of Wassef R et al. who demonstrated adequate anesthesia for short perianal surgery with the use of 1.5 mg spinal hyperbaric bupivacaine. Bupivacaine was prepared immediately before injection by an independent anesthesiologist and was administered by a second anesthesiologist. Block assessment and clinical follow-up of the patients was also performed by a third anesthesiologist. The following data were recorded; Patient demographics, duration of anesthesia and surgery, level of sensory and motor block immediately before surgery, at the end of the surgery, and every 30 minutes until resolution of the block. NIBP and HR were documented every 5 minutes in the OR and PACU. Also Times to ambulation, first voiding time, and time to home discharge were recorded. Patient's and surgeon's satisfaction were evaluated with a 4-point score (0=poor, 1=good, 2=very good, 3= excellent). Patients were followed by phone call to note down any possible postoperative complication (postdural puncture headache, TNS or backache) at day 1 postoperatively and 10 days later. The time of the dural puncture was used as the primary starting point of assessment.

Interventions

DRUGDixon's up-and-down method

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.

Sponsors

Imam Abdulrahman Bin Faisal University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Minimal Effective Dose of Hyperbaric Bupivacaine10 min after dural puncturethe 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.

Secondary

MeasureTime frameDescription
Sacral Level of Sensory Blockevery 30 min until complete regression of the block (approximately 90 min)The level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions
Motor Block Score as Assessed Using the Bromage Scaleevery 30 min until Time to ambulation (approximately 2 hours)The motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block). A successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia).
Patient's Satisfactions24 hours after surgeryPatient's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction
Surgeon's Satisfactions24 hours after procedureSurgeon's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction

Participant flow

Recruitment details

Four independent anesthetists were assigned for the study from January 2014.one to select patients in the anesthesia clinic, the 2nd to prepare the studied drug in the OR, the 3rd one to inject the drug and the 4th one was to collect the data

Pre-assignment details

35 patients were enrolled However; after they have signed the consent. 7 patients were excluded because they have received analgesics in the morning of surgery. and 4 patients refused the saddle block in the operating room. So actually 24 patients out of 35 participants underwent intervention. That has been already specified in the protocol

Participants by arm

ArmCount
Saddle Block
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 Dixon's up-and-down method: 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.
24
Total24

Withdrawals & dropouts

PeriodReasonFG000
Overall Studypatients were excluded from the study11

Baseline characteristics

CharacteristicSaddle Block
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
24 Participants
Age, Continuous33.71 years
STANDARD_DEVIATION 10.24
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
24 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
Saudi Arabia
24 Participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
15 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 24
other
Total, other adverse events
0 / 24
serious
Total, serious adverse events
0 / 24

Outcome results

Primary

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.

Time frame: 10 min after dural puncture

ArmMeasureValue (MEAN)
Single Group Study / Saddle BlockMinimal Effective Dose of Hyperbaric Bupivacaine1.9 milligrams
Comparison: Descriptive statistics were considered to calculate the mathematic mean (SD) of demographic, surgical, and other postoperative continuous data and to calculate the median (range) of sensory and motor block levels, as well as the degree of patient and surgeon satisfaction95% CI: [1.7, 2.1]
Secondary

Motor Block Score as Assessed Using the Bromage Scale

The motor block was tested by a modified Bromage scale (0 = no motor block, 1 = able to flex the ankle and bend knees, 2 = able to flex ankle, and 3 = full motor block). A successful block was defined as one that was sufficient to proceed with the surgery without any supplementation (intravenous analgesic, local anesthetic infiltration, or general anesthesia).

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

Population: The block characteristics for patients with successful block (12 patients)

ArmMeasureGroupValue (MEDIAN)
Single Group Study / Saddle BlockMotor Block Score as Assessed Using the Bromage ScaleImmediately before surgery0 score on a scale
Single Group Study / Saddle BlockMotor Block Score as Assessed Using the Bromage ScaleAt conclusion of surgery 0 Aided patient positioni0 score on a scale
Secondary

Patient's Satisfactions

Patient's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction

Time frame: 24 hours after surgery

Population: All patient with successful block were satisfied

ArmMeasureValue (MEDIAN)
Single Group Study / Saddle BlockPatient's Satisfactions3 score on a scale
Secondary

Sacral Level of Sensory Block

The level of sensory block was tested using a long surgical toothless clamp gently applied radially, starting from the anal orifice, in different diagonal directions

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

Population: * Immediately before surgery S4 (S3-S4)~* At conclusion of surgery S4 (S3-S4)~* Maximum blocked dermatome S4 (S3-S4)

ArmMeasureGroupValue (MEDIAN)
Single Group Study / Saddle BlockSacral Level of Sensory BlockMaximum blocked dermatome4 Sacral level of sensory block
Single Group Study / Saddle BlockSacral Level of Sensory BlockAt conclusion of surgery4 Sacral level of sensory block
Single Group Study / Saddle BlockSacral Level of Sensory BlockImmediately before surgery4 Sacral level of sensory block
Secondary

Surgeon's Satisfactions

Surgeon's satisfactions were evaluated with a 4-point satisfaction score (0=poor satisfaction, 1=good satisfaction 2=very good satisfaction, 3= excellent satisfaction

Time frame: 24 hours after procedure

Population: All surgeon who operated on the patient with successful block (12 patients ) were satisfied

ArmMeasureValue (MEDIAN)
Single Group Study / Saddle BlockSurgeon's Satisfactions3 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026