Perianal SurgeryPhase 3NCT02299167
Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block
A Phase 3 study testing Dixon's up-and-down method in people with Perianal Surgery, run by Imam Abdulrahman Bin Faisal University.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Perianal Surgery
- What is being tested?
- Dixon's up-and-down method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists physical Status I and II patients.
- Scheduled for outpatient elective perianal surgery.
Who cannot join
- 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.
About this study
Official title: The Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Successful Reliable Saddle Block for Minor Perianal Surgeries
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).
Read more
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.
Read the 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.
- Conditions
- Perianal Surgery
- Being tested
- Dixon's up-and-down method
- Keywords
- Perianal surgery, hyperbaric bupivacaine, saddle block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dixon's up-and-down methodDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Dixon's up-and-down method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 min after dural puncture
Secondary outcomes (4)
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
Measured: every 30 min until complete regression of the block (approximately 90 min)
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).
Measured: every 30 min until Time to ambulation (approximately 2 hours)
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
Measured: 24 hours after surgery
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
Measured: 24 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Perianal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roshdi Al Metwalli, MD, Principal investigator, Associate Professor at Anesthesiology Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299167
- Sponsor's protocol ID
- ANE-2014-1-23
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2014
- Last updated
- 24 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Successful Reliable Saddle Block for Minor Perianal Surgeries
- ClinicalTrials.gov ID
- NCT02299167
- Acronym / sponsor ID
- ANE-2014-1-23
- Conditions
- Perianal Surgery
- Keywords
- Perianal surgery, hyperbaric bupivacaine, saddle block
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 24 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saddle block | Experimental | Drug: Dixon's up-and-down methodThe 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 |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists physical Status I and II patients.
- Scheduled for outpatient elective perianal surgery.
Key exclusion criteria (8 listed)
- Patients unwilling to participate.
- Contraindications to regional anesthesia.
- Morbid obesity.
- Bleeding disorders.
- Mental health problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dixon's up-and-down methodusing 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. | Drug | Saddle block |
Primary outcome
Minimal Effective Dose of Hyperbaric Bupivacaine
Time frame: 10 min after dural puncture
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.
4 secondary outcomes
Sacral Level of Sensory Block
Time frame: every 30 min until complete regression of the block (approximately 90 min)
Motor Block Score as Assessed Using the Bromage Scale
Time frame: every 30 min until Time to ambulation (approximately 2 hours)
Patient's Satisfactions
Time frame: 24 hours after surgery
Surgeon's Satisfactions
Time frame: 24 hours after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshdi Al Metwalli, MD principal investigator
Associate Professor at Anesthesiology Dept
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dixon's up-and-down method in people with Perianal Surgery, run by Imam Abdulrahman Bin Faisal University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Effective Dose of Hyperbaric Bupivacaine (time frame: 10 min after dural puncture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.