Trial Outcomes & Findings for Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery (NCT NCT01243593)

Results Overview

The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

32 participants

Primary outcome timeframe

Time in recovery room, approximately 60-90 minutes.

Results posted on

2021-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.	Control Group Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group n=16 Participants Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.	Control Group n=16 Participants Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.	Total n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	16 Participants n=93 Participants	16 Participants n=4 Participants	32 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	0.7 years STANDARD_DEVIATION 0.2 • n=93 Participants	1 years STANDARD_DEVIATION 0.3 • n=4 Participants	0.85 years STANDARD_DEVIATION 1 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	9 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	7 Participants n=4 Participants	19 Participants n=27 Participants
Weight	8.4 kg STANDARD_DEVIATION 0.62 • n=93 Participants	9.2 kg STANDARD_DEVIATION 0.92 • n=4 Participants	8.7 kg STANDARD_DEVIATION 3 • n=27 Participants

PRIMARY outcome

Timeframe: Time in recovery room, approximately 60-90 minutes.

The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.

Outcome measures

Outcome measures
Measure	Treatment Group n=16 Participants Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.	Control Group n=16 Participants Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Requirement for Morphine Post-surgery.	13 Participants	6 Participants

SECONDARY outcome

Timeframe: Time in recovery room, approximately 60-90 minutes.

Patients will receive intravenous morphine 0.05 mg/kg if the FLACC is ≥ 3/10 (equivalent to mild-to-moderate pain). Morphine may be given at 10 minute intervals as per standard protocol until the FLACC score is \< 3/10, or the child declines additional pain medicine when offered.

Outcome measures

Outcome measures
Measure	Treatment Group n=16 Participants Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.	Control Group n=16 Participants Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Total Amount of Morphine (mg/kg) Administered in the Recovery Room.	0.07 mg/kg Standard Deviation 0.05	0.03 mg/kg Standard Deviation 0.04

SECONDARY outcome

Timeframe: On arrival to recovery room.

Pain scores will be assessed using the Faces-Legs-Activity-Cry-Consolibility (FLACC) scale for children ≤ 7 years old. The FLACC scale is from 0-10 (0=no pain, 10=worst pain). The scale is composed of five subscales (Faces = facial expression; Legs = lower extremity movement; Activity = degree of movement; Cry = how upset the child is; Consolibity = how easy the child can be consoled). Eacg subscale is rated 0 to 2 (0 = rated as comfortable, no or minimal discomfort for that subscale; 2 = rated as uncomfortable, in pain according to that subscale). The subscales are summed to give a composite score out of 10. Pain scores will be assessed at admission to the recovery room.

Outcome measures

Outcome measures
Measure	Treatment Group n=16 Participants Transversus Abdominis Plane Block: A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.	Control Group n=16 Participants Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Assessment of First Pain Score on Arrival to Recovery Room.	5 units on FLACC pain scale Standard Deviation 5	2 units on FLACC pain scale Standard Deviation 3

Adverse Events

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

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. Jason Hayes

Sick Kids Hospital

Phone: 416-813-7445

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place