Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery

• Sponsor: The Hospital for Sick Children (Other)
• Overall Status: Completed
• CT.gov ID: NCT01243593
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effectiveness of transversus abdominis plane (TAP) block in reducing postoperative opioid requirements and pain after open pyeloplasty surgery in children.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Procedure: Transversus Abdominis Plane Block; Procedure: Standard Anesthesia	N/A

Detailed Description

Primary open pyeloplasty is a common elective surgical procedure at The Hospital for Sick Children. All children are given fentanyl plus local anesthetic wound infiltration for intraoperative analgesia. A retrospective audit demonstrated that 63% of children required additional opioid treatment in the early recovery period following surgery. Concern exists regarding potential side effects of opioids including nausea or vomiting, respiratory depression, pruritus, over-sedation and delayed transition to oral intake. More importantly, children may under-report their pain or pain may not be recognized by medical staff leading to inadequate provision of analgesia. This suggests that the use of a regional technique, such as a TAP block, may benefit children undergoing open pyeloplasty.

The ultrasound guided TAP block introduces a local anaesthetic to the transversus abdominis plane which is one of three muscle layers in the abdominal wall. This results in a block of the nerves leading to the abdominal wall thereby reducing pain sensations.

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transversus Abdominis Plane Block in Children Undergoing Open Pyeloplasty Surgery
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Group	Procedure: 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.
Active Comparator: Control Group	Procedure: Standard Anesthesia; Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.

Outcome Measures

Primary Outcome Measures

1. Requirement for Morphine Post-surgery. [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.

Secondary Outcome Measures

1. Total Amount of Morphine (mg/kg) Administered in the Recovery Room. [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.

2. Assessment of First Pain Score on Arrival to Recovery Room. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) classification score 1-3

• age 1 month to 6 years inclusive

Exclusion Criteria:

• children undergoing an additional surgical procedure at an anatomical location not covered by a unilateral TAP block during the same anesthetic

• children in whom a TAP block is contraindicated, i.e. surgical scar or distorted anatomy at the site of injection

• postoperative admission to the intensive care unit

• children with a known allergy to bupivacaine

• children with a history of chronic abdominal pain requiring opioid analgesics

• children with known renal insufficiency

• children with known impaired hepatic function

• children with known impaired cardiac function

• children known hypersensitivity to sodium metabisulfite

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Hospital for Sick Children	Toronto	Ontario	Canada	M5G 1X8

Sponsors and Collaborators

• The Hospital for Sick Children

Investigators

• Principal Investigator: Jason Hayes, MD, The Hospital for Sick Children, Toronto Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children
• ClinicalTrials.gov Identifier: NCT01243593
• Other Study ID Numbers: 1000019942
• First Posted: Nov 18, 2010
• Last Update Posted: Feb 4, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Jason Hayes, Staff Anesthesiologist, The Hospital for Sick Children: pediatrics; anesthesia; pyeloplasty; Transversus Abdominis Plane Block; Regional Anesthesia
• Additional relevant MeSH terms: Anesthetics

Study Results

Participant Flow

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	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.	Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Period Title: Overall Study
STARTED	16	16
COMPLETED	16	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Treatment Group	Control Group	Total
Arm/Group Description	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.	Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.	Total of all reporting groups
Overall Participants	16	16	32
Age (Count of Participants)
<=18 years	16 100%	16 100%	32 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	0.7 (0.2)	1 (0.3)	0.85 (1)
Sex: Female, Male (Count of Participants)
Female	4 25%	9 56.3%	13 40.6%
Male	12 75%	7 43.8%	19 59.4%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	8.4 (0.62)	9.2 (0.92)	8.7 (3)

Outcome Measures

1. Primary Outcome

Title	Requirement for Morphine Post-surgery.
Description	The primary outcome measure will be the count and percentage of children who require morphine in the recovery room.
Time Frame	Time in recovery room, approximately 60-90 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	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.	Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Measure Participants	16	16
Count of Participants [Participants]	13 81.3%	6 37.5%

2. Secondary Outcome

Title	Total Amount of Morphine (mg/kg) Administered in the Recovery Room.
Description	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.
Time Frame	Time in recovery room, approximately 60-90 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	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.	Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Measure Participants	16	16
Mean (Standard Deviation) [mg/kg]	0.07 (0.05)	0.03 (0.04)

3. Secondary Outcome

Title	Assessment of First Pain Score on Arrival to Recovery Room.
Description	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.
Time Frame	On arrival to recovery room.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment Group	Control Group
Arm/Group Description	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.	Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
Measure Participants	16	16
Mean (Standard Deviation) [units on FLACC pain scale]	5 (5)	2 (3)

Adverse Events

Arm/Group Title	Treatment Group		Control Group
Arm/Group Description	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.		Standard Anesthesia: Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
All Cause Mortality
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/16 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.