## Protocol Section
### Identification Module
**NCT ID:** NCT06420336

**Brief Title:** QL vs LAI for Palatoplasty

**Official Title:** Quadratus Lumborum Block for Pain Control in Unilateral Anterior Iliac Bone Graft Harvesting for Pediatric Patients Undergoing Palatoplasty: a Prospective Randomized Control Trial

#### Organization Study ID Info
**ID:** Pro00136697
#### Organization
**Class:** OTHER
**Full Name:** Medical University of South Carolina
### Status Module
#### Completion Date
**Date:** 2026-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-07-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-07-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Medical University of South Carolina

#### Responsible Party

**Investigator Affiliation:** Medical University of South Carolina

**Investigator Full Name:** Nicole McCoy

**Investigator Title:** Assistant Professor-Faculty

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

### Conditions Module

**Conditions:**

- Post-operative Pain

- Opioid Use

- Cleft Palate

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 46

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance.

**Intervention Names:**

- Procedure: Quadratus lumborum block

**Label:** Quadratus lumborum block

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case. After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.

**Intervention Names:**

- Procedure: Local anesthetic infiltration

**Label:** Local anesthetic infiltration

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Quadratus lumborum block

**Description:** After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance.

**Name:** Quadratus lumborum block

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Local anesthetic infiltration

**Description:** After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.

**Name:** Local anesthetic infiltration

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Using the Wong-Baker FACES Pain Rating Scale, patients will report their average pain from 0 hours post-op through 48-hours post-op at various intervals. In the Post-Anesthesia Recovery Unit, pain scores will be evaluated every 15 minutes as clinically able, until discharged from the PACU. On Post-Op Day 1 at 9:00 am, pains average pain score from discharge to PACU to midnight will be reported. At approximately 24-hours after surgery ends, pain scores from midnight to 23-hours post-op will be reported, then at the 48-hour post-op mark, pain scores from 24-hr post op to 48-hour post-op time will be recorded.

**Measure:** Pain Scores

**Time Frame:** 0-48 hours after surgery ends

#### Secondary Outcomes

**Description:** Subjects will report the date and time that resolution of numbness over operative hip occurs or feeling of pain in operative hip returns.

**Measure:** Time to block resolution

**Time Frame:** up to 7 days after surgery ends

**Description:** Total morphine milligram equivalents (MME) will be calculated from pre-op to 48-hours after surgery ends.

**Measure:** Opioid Consumption up to 48 hours after surgery ends

**Time Frame:** From the pre-operative phase up to 48 hours after surgery ends

**Description:** Complications associated with study participation will be evaluated.

**Measure:** Number of complications associated with each intervention

**Time Frame:** From the time the intervention is administered up to 48-hours after surgery ends.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria

* Patients undergoing palatoplasty with autologous bone graft from the anterior iliac crest.
* Ages 6-18 years of age
* Planned admission post-op
* ASA Status Range: 1-3

Exclusion Criteria

* Contraindication to QL blocks or LAI which may include:
* overlying infection skin at the block needle insertion site
* coagulopathies
* known bleeding disorders
* Allergy to local anesthetic
* Cognitive or developmental impairment that would limit ability to report pain.
* Non-English Speaking/Writing
* Subjects or their parent/guardian unable or choose to not give informed consent/assent.

**Maximum Age:** 18 Years

**Minimum Age:** 6 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nitchie@musc.edu

**Name:** Haley Nitchie, MHA

**Phone:** 843-792-1869

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Charleston

**Contacts:**

***Contact 1:***

- **Email:** nitchie@musc.edu

- **Name:** Haley Nitchie, MHA

- **Phone:** 843-792-1869

- **Role:** CONTACT

**Country:** United States

**Facility:** Medical University of South Carolina

**State:** South Carolina

**Zip:** 29425

#### Overall Officials

**Official 1:**

**Affiliation:** Medical University of South Carolina

**Name:** Nicole McCoy, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000007569

- Term: Jaw Abnormalities

- ID: D000007571

- Term: Jaw Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000019767

- Term: Maxillofacial Abnormalities

- ID: D000019465

- Term: Craniofacial Abnormalities

- ID: D000009139

- Term: Musculoskeletal Abnormalities

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000009056

- Term: Mouth Abnormalities

- ID: D000009059

- Term: Mouth Diseases

- ID: D000018640

- Term: Stomatognathic System Abnormalities

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M13069

- Name: Pain, Postoperative

- Relevance: HIGH

- As Found: Post Operative Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6207

- Name: Cleft Palate

- Relevance: HIGH

- As Found: Cleft Palate

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M10599

- Name: Jaw Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M10601

- Name: Jaw Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21671

- Name: Maxillofacial Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M21420

- Name: Craniofacial Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12096

- Name: Musculoskeletal Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12016

- Name: Mouth Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20727

- Name: Stomatognathic System Abnormalities

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002972

- Term: Cleft Palate

- ID: D000010149

- Term: Pain, Postoperative

### Intervention Browse Module - Ancestors

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: AnEm

- Name: Antiemetics

- Abbrev: Gast

- Name: Gastrointestinal Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Ot

- Name: Other Dietary Supplements

### Intervention Browse Module - Browse Leaves

- ID: M7102

- Name: Dexamethasone

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- Relevance: HIGH

- As Found: Process

- ID: M1700

- Name: Ropivacaine

- Relevance: LOW

- As Found: Unknown

- ID: M4109

- Name: Anesthetics, Local

- Relevance: HIGH

- As Found: Influenza Vaccine

- ID: M235549

- Name: Dexamethasone acetate

- Relevance: LOW

- As Found: Unknown

- ID: M4854

- Name: Benzocaine

- Relevance: LOW

- As Found: Unknown

- ID: T433

- Name: Tannic Acid

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000777

- Term: Anesthetics

- ID: D000000779

- Term: Anesthetics, Local

### Misc Info Module

- Version Holder: 2024-05-31
