Trial Outcomes & Findings for Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block (NCT NCT02299167)

Last Updated: 2020-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

10 min after dural puncture

Results posted on

2020-11-24

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Single Group Study / 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.
Overall Study STARTED	35
Overall Study Dural Puncture	24
Overall Study Success Rate	24
Overall Study Adverse Effects	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Group Study / 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.
Overall Study patients were excluded from the study	11

Baseline Characteristics

Minimal Effective Dose of Hyperbaric Spinal Bupivacaine for Saddle Block

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saddle Block n=24 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	33.71 years STANDARD_DEVIATION 10.24 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	24 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Saudi Arabia	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 10 min after dural puncture

Outcome measures

Outcome measures
Measure	Single Group Study / Saddle Block n=24 Participants 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.
Minimal Effective Dose of Hyperbaric Bupivacaine	1.9 milligrams Interval 1.7 to 2.1

SECONDARY outcome

Timeframe: 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)

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

Outcome measures

Outcome measures
Measure	Single Group Study / Saddle Block n=12 Participants 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.
Sacral Level of Sensory Block Maximum blocked dermatome	4 Sacral level of sensory block Interval 3.0 to 4.0
Sacral Level of Sensory Block At conclusion of surgery	4 Sacral level of sensory block Interval 3.0 to 4.0
Sacral Level of Sensory Block Immediately before surgery	4 Sacral level of sensory block Interval 3.0 to 4.0

SECONDARY outcome

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

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

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).

Outcome measures

Outcome measures
Measure	Single Group Study / Saddle Block n=12 Participants 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.
Motor Block Score as Assessed Using the Bromage Scale Immediately before surgery	0 score on a scale Interval 0.0 to 0.0
Motor Block Score as Assessed Using the Bromage Scale At conclusion of surgery 0 Aided patient positioni	0 score on a scale Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 hours after surgery

Population: All patient with successful block were satisfied

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

Outcome measures

Outcome measures
Measure	Single Group Study / Saddle Block n=12 Participants 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.
Patient's Satisfactions	3 score on a scale Interval 2.0 to 3.0

SECONDARY outcome

Timeframe: 24 hours after procedure

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

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

Outcome measures

Outcome measures
Measure	Single Group Study / Saddle Block n=12 Participants 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.
Surgeon's Satisfactions	3 score on a scale Interval 2.0 to 3.0

Adverse Events

Single Group Study / Saddle Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roshdi R. Al-Metwalli

Dammam University

Phone: +966 50 289 3485

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place