Trial Outcomes & Findings for Optimizing Anesthesia for Post Partum Tubal Ligations (NCT NCT03993314)

Results Overview

Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

10 minutes after spinal injection

Results posted on

2021-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	Bupivacaine 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Overall Study STARTED	9	6
Overall Study COMPLETED	9	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural	Total n=15 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 4.5 • n=9 Participants	27.0 years STANDARD_DEVIATION 3.7 • n=6 Participants	28.3 years STANDARD_DEVIATION 4.2 • n=15 Participants
Sex: Female, Male Female	9 Participants n=9 Participants	6 Participants n=6 Participants	15 Participants n=15 Participants
Sex: Female, Male Male	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=15 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	9 participants n=9 Participants	6 participants n=6 Participants	15 participants n=15 Participants
Body Mass Index (BMI)	33.0 kg/m^2 STANDARD_DEVIATION 7.1 • n=9 Participants	31.7 kg/m^2 STANDARD_DEVIATION 5.3 • n=6 Participants	32.5 kg/m^2 STANDARD_DEVIATION 6.3 • n=15 Participants

PRIMARY outcome

Timeframe: 10 minutes after spinal injection

Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). A level of numbness of T6 or higher is required for an adequate surgical block. Participants are classified as having either an adequate level of numbness (T1, T2, T3, T4, T5, or T6) or an inadequate level (T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4).

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Number of Patients Who Achieve a Level of Numbness of T6 or Higher Adequate level of numbness	8 Participants	5 Participants
Number of Patients Who Achieve a Level of Numbness of T6 or Higher Inadequate level of numbness	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 10 minutes after spinal injection

The degree to which participants experience analgesia. Degree of analgesia is determined by the level of the block. Block level may be T1 (highest level of numbness), T2, T3, T4, T5, T6, T7,T8, T9 , T10, T11, T12, L1, L2, L3, or L4 (lowest level or numbness). Participants are assigned a numerical score according to level of the block. Numerical scores were assigned so that a higher score indicates better outcome (i.e., greater level of numbness): T1 = 16 points; T2 = 15 points; T3 = 14 points; T4 = 13 points; T5 = 12 points; T6 = 11 points; T7 = 10 points; T8 = 9 points; T9 = 8 points; T10 = 7 points; T11 = 6 points; T12 = 5 points; L1 = 4 points; L2 = 3 points; L3 = 2 points; L4 = 1 point

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Level of Numbness	15 score on a scale Interval 13.0 to 16.0	12.5 score on a scale Interval 12.0 to 15.0

SECONDARY outcome

Timeframe: Day of surgery

Number of patients who required epidural activation

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Epidural Activation Epidural activated	5 Participants	1 Participants
Epidural Activation Epidural not activated	4 Participants	5 Participants

SECONDARY outcome

Timeframe: Day of surgery

Number of patients who required supplemental intravenous sedation or general anesthesia

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Supplemental Intravenous Sedation or General Anesthesia Supplemental IV sedation or general anesthesia	5 Participants	3 Participants
Supplemental Intravenous Sedation or General Anesthesia No supplemental IV sedation or general anesthesia	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 10 minutes after spinal injection

The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Modified Bromage Score at 10 Minutes Post-injection 0 = Ability to maintain leg lift for prolonged period	1 Participants	0 Participants
Modified Bromage Score at 10 Minutes Post-injection 1 = Ability to lift legs briefly	2 Participants	0 Participants
Modified Bromage Score at 10 Minutes Post-injection 2 = Ability to bend knees	4 Participants	0 Participants
Modified Bromage Score at 10 Minutes Post-injection 3 = Ability to wiggle toes	2 Participants	3 Participants
Modified Bromage Score at 10 Minutes Post-injection 4 = No movement of lower extremities	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 60 minutes after spinal injection

The modified Bromage score is an ordinal scale ranging from 0 to 4 with higher values indicating greater levels of numbness. 0 = ability to maintain leg lift for prolonged period; 1 = ability to lift legs briefly; 2 = ability to bend knees; 3 = ability to wiggle toes; 4 = no movement of lower extremities

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Modified Bromage Score 60 Minutes After Intrathecal Injection 0 = Ability to maintain leg lift for prolonged period	2 Participants	0 Participants
Modified Bromage Score 60 Minutes After Intrathecal Injection 3 = Ability to wiggle toes	2 Participants	1 Participants
Modified Bromage Score 60 Minutes After Intrathecal Injection 4 = No movement of lower extremities	2 Participants	1 Participants
Modified Bromage Score 60 Minutes After Intrathecal Injection 1 = Ability to lift legs briefly	2 Participants	1 Participants
Modified Bromage Score 60 Minutes After Intrathecal Injection 2 = Ability to bend knees	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Day of surgery

Time required for readiness for discharge from Post Anesthesia Care Unit (PACU)

Outcome measures

Outcome measures
Measure	Bupivacaine n=9 Participants 1 ml 0.5% isobaric bupivacaine (5 mg) + 15 mcg fentanyl intrathecal plus epidural volume extension (EVE) Bupivacaine: 1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural	Chloroprocaine n=6 Participants 5 ml 1% spinal chloroprocaine (50 mg) intrathecal plus epidural volume extension (EVE) Chloroprocaine: Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
Time to PACU Discharge	57 minutes Interval 15.0 to 143.0	45 minutes Interval 21.0 to 93.0

Adverse Events

Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chloroprocaine

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

Dr. Mark Powell

University of Alabama at Birmingham

Phone: 205-934-6007

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place