ITM vs QL for Pediatric Open Lower Abdominal Procedures

Pediatrics Clinical Trial

Official title:

Intrathecal Morphine Versus Bilateral Quadratus Lumborum Blocks for Perioperative Analgesia in Pediatric Patients Undergoing Open Lower Abdominal Procedures: A Prospective Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05506930
• Other study ID #: Pro00121082
• Status: Recruiting
• Phase: Phase 4
• Start date: August 17, 2022
• Est. completion date: February 1, 2027

Study information

• Verified date: October 2023
• Source: Medical University of South Carolina
• Contact: Haley Nitchie, MHA
• Phone: 843-792-1869
• Email: nitchie[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients between the ages of 12 months and 11 years who are undergoing an open lower abdominal procedure will be randomized to receive intrathecal morphine, or bilateral quadratus lumborum block. The investigators will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of pain control as demonstrated by charted pain scores and morphine equivalents in the first 48 hours. This study will also assess the side effects of each intervention such as nausea and vomiting, and itching.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 1, 2027
• Est. primary completion date: July 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 11 Years

Eligibility

Inclusion Criteria:

• Ages 12 months to 11 years old

• Undergoing an open lower abdominal procedure

Exclusion Criteria:

• Allergy to morphine or amide local anesthetics

• Localized rash at site of planned regional anesthetic block

• Bleeding diathesis

• Spinal dysmorphism

• Previous spinal surgery with instrumentation of the lumbar spine

• Inability or unwillingness of parent or legal guardian to give informed consent.

• Prior enrollment and randomization in this study

Related Conditions & MeSH terms

• Intrathecal Morphine
• Pain Control
• Pediatrics

Intervention

Drug:
• Intrathecal Morphine
One group of subjects will receive intrathecal morphine: spinal (neuraxial) dose of preservative free morphine (Duramorph), usually about 4-5mcg/kg. This is injected into the cerebrospinal fluid under sterile technique by a pediatric anesthesiologist while the subject is already under general anesthesia. This procedure is well-described in the pediatric population and used regularly for postoperative pain relief for a variety of procedures including ureteral reimplantation.
• Quadratus lumborum block
The second group of subjects will have bilateral quadratus lumborum blocks: peripheral nerve block utilizing ropivacaine 0.2%, usually about ½ mL per/ kg per side (total dose approximately 1mL/kg). This is injected in the subject's flank in the fascial plane between the quadratus lumborum muscle and the psoas muscle. Ultrasound guidance is used for needle and structure localization and this procedure is done by a pediatric anesthesiologist while the subject is already under general anesthesia. Quadratus lumborum blocks are regularly used in clinical practice for postoperative pain relief for a variety of abdominal procedures.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of analgesia	The primary endpoint will compare the effect that intrathecal morphine and quadratus lumborum blocks have on the duration of analgesia as demonstrated by charted pain scores and morphine equivalents in the first 24 hours.	Up to 24 hours post-op
Secondary	Side effects of each intervention	The secondary endpoint will assess the side effects of each intervention such as nausea and vomiting, and pruritis.	up to 48 hours post-operative
Secondary	Patient/Family Satisfaction	This endpoint will assess patient and family overall satisfaction with their child's pain control and experience of their child's post-op recovery. Satisfaction will be rated using VAS 0 (not satisfied) to 100 (completely satisfied).	up to 48 hours post-operative
Secondary	Total Length of PACU and Hospital Stay	This endpoint will assess how long the patient's PACU stay was in days, and how long their hospital stay overall was, also in days.	time to discharge after surgery, (an expected average length of hospital stay is approximately 2-4 days)