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A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks (QLB)vs Intrathecal Morphine(ITM) for Post Cesarean Section Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368364
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
Sudipta Sen, The University of Texas Health Science Center, Houston

Brief Summary:
the purpose of this study is to compare opioid consumption in morphine equivalents between the groups that received postoperative analgesia with intrathecal morphine versus US guided QL blocks versus US guided QL catheters

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Intrathecal morphine sulfate (ITM) Drug: Bupivacaine hydrochloride Drug: ropivacaine hydrochloride Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Control Trial Comparing Analgesic Benefits of Ultrasound-guided Single vs Continuous Quadratus Lumborum Blocks vs Intrathecal Morphine for Post Cesarean Section Pain
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : April 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Group 1 (Control group) Drug: Intrathecal morphine sulfate (ITM)
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion

Experimental: Group 2(Bupivacaine hydrochloride group) Drug: Bupivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion

Experimental: Group 3 (ropivacaine hydrochloride group) Drug: ropivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride




Primary Outcome Measures :
  1. Total narcotic consumption in morphine equivalents (in milligrams) [ Time Frame: upto 72 hours post surgery ]

Secondary Outcome Measures :
  1. Total narcotic consumption in morphine equivalents (in milligrams) [ Time Frame: 12,24,48 hours post surgery ]
  2. pain as measured by the numerical pain score (NPS) [ Time Frame: 6, 12, 24, 48 and 72 hours post surgery ]
    NPS is a 11-point scale with a higher number indicating more severe pain

  3. Number of patients showing side effects of pruritus [ Time Frame: 24, 48 and 72 hours post surgery ]
    This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect

  4. Number of patients showing side effects of nausea [ Time Frame: 24, 48 and 72 hours post surgery ]
    This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect

  5. Number of patients showing side effects of vomiting [ Time Frame: 24, 48 and 72 hours post surgery ]
    This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect

  6. Number of patients showing side effects of sedation [ Time Frame: 24, 48 and 72 hours post surgery ]
    This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect

  7. Patient satisfaction will be measured on a Likert scale (5 points) ranging form extremely satisfied to not satisfied. [ Time Frame: 48 and 72 hours post surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Elective C section via Pfannenstiel incision
  • Living singleton pregnancy
  • Gestation week at least 37 weeks
  • American Society of Anesthesiologists (ASA) status 1, 2 and 3
  • Primary and secondary C sections

Exclusion Criteria:

  • Chronic pain
  • Opioid tolerant patients
  • Allergy to drugs used in the study.
  • Cognitive dysfunction
  • BMI > 40
  • Coagulation disorder
  • Local infection
  • Inability to tolerate oral medication
  • Previous intra-abdominal surgery
  • Patients who will receive a combined spinal epidural for their C section
  • Local anesthetics injected at any other fascial plane except the QLB plane (for e.g.- local wound infiltration by surgeon)
  • Patients who received sedation or general anesthesia during their C section (midazolam, ketamine, fentanyl, propofol, hydromorphone)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368364


Contacts
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Contact: Sudipta Sen, MD (713) 500-6200 Sudipta.Sen@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital TMC Recruiting
Houston, Texas, United States, 77030
Contact: Sudipta Sen, MD         
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Sudipta Sen, MD    713-500-6200    Sudipta.Sen@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Sudipta Sen, MD The University of Texas Health Science Center, Houston
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Responsible Party: Sudipta Sen, Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04368364    
Other Study ID Numbers: HSC-MS-20-0143
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sudipta Sen, The University of Texas Health Science Center, Houston:
post c section pain
pain control after baby
nerve block for post delivery pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Morphine
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics