ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain

NCT03261193 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: PRO16120234
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

Conditions

Pain, Postoperative

Keywords

quadratus lumborum block; post-operative pain; cesarean section pain; analgesia; nerve block

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS) Pain Score With Movement

  Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.

  24 hours after surgical procedure (cesarean delivery)

Secondary Outcomes (26)

• Breast Feeding Success/Quality

  24-hours post-operatively

• Visual Analogue Scale (VAS) Pain Score at Rest

  1 hour after intervention

• First Request for Pain Medication

  From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours

• Sedation

  24-hours post-operative

• Pruritis

  4-hours post-operative

Study Arms (2)

ITM + Sham QLB

SHAM COMPARATOR

Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.

Drug: ITM + Sham QLB

ITM + Bupivacaine QLB

EXPERIMENTAL

Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.

Drug: ITM + Bupivacaine QLB

Interventions

ITM + Sham QLB DRUG

Sham subcutaneous non-anesthetic infiltration with saline

Also known as: Saline

ITM + Sham QLB

ITM + Bupivacaine QLB DRUG

QL plane block with local anesthesia

Also known as: Bupivacaine

ITM + Bupivacaine QLB

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective cesarean planned under spinal anesthesia
• Singleton pregnancy
• American Society of Anesthesiologists (ASA) classification score of 2 (or less)
• Gestational age of at least 37 weeks
• Intention to breastfeed infant

You may not qualify if:

• Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
• Anatomical abnormalities contraindicating spinal or QLB placement
• Received/Conversion to general anesthesia
• Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
• History of chronic pain
• History of chronic opioid use/abuse
• History of Subutex, methadone, other maintenance therapy

Sponsors & Collaborators

• Nicholas Schott: lead

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

SLC22A18 protein, human; Sodium Chloride; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Nicholas Schott, MD
• Organization: UPMC

schottnj@upmc.edu

412-692-4503

Study Officials

• Amy Monroe

  University of Pittsburgh

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 24, 2017
• Study Start: September 5, 2017
• Primary Completion: June 25, 2018
• Study Completion: November 11, 2022
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)