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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04368364
• Other study ID #: HSC-MS-20-0143
• Status: Terminated
• Phase: Phase 4
• Start date: May 22, 2020
• Est. completion date: June 29, 2020

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: June 29, 2020
• Est. primary completion date: June 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Intrathecal morphine sulfate (ITM)
Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
• Bupivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
• ropivacaine hydrochloride
Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital TMC	Houston	Texas
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Narcotic Consumption in Morphine Equivalents (in Milligrams)	Total narcotic consumption in morphine equivalents (in milligrams) for the first 72 hours after surgery was calculated.	upto 72 hours post surgery
Secondary	Total Narcotic Consumption in Morphine Equivalents (in Milligrams)	Total narcotic consumption in morphine equivalents (in milligrams) for 12, 24 and 48 hours after surgery was calculated.	12,24,48 hours post surgery
Secondary	Static Pain as Measured by the Numerical Pain Score (NPS)	To assess static pain scores, NPS will be recorded while the participant is supine in bed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).	6, 12, 24, 48 and 72 hours post surgery
Secondary	Severity of Pruritus as Assessed by a Scale	This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.	24, 48 and 72 hours post surgery
Secondary	Severity of Nausea as Assessed by a Scale	This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.	24, 48 and 72 hours post surgery
Secondary	Severity of Vomiting as Assessed by a Scale	This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.	24, 48 and 72 hours post surgery
Secondary	Severity of Sedation as Assessed by a Scale	This numeric scale is a 11-point scale with a higher number indicating an extremely severe side effect. Total score ranges from 0 to 10.	24, 48 and 72 hours post surgery
Secondary	Patient Satisfaction as Assessed by Likert Scale	Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn.; Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).	24 hours post surgery
Secondary	Dynamic Pain as Measured by the Numerical Pain Score (NPS)	To assess dynamic pain scores, the participant be asked to sit up in bed from supine to sitting, and the NPS will then be recorded. If the participant is ambulating, the dynamic pain score during ambulation (rather during sitting) will be assessed. NPS is a 11-point scale with a higher number indicating more severe pain (total score ranges from 0 to 10).	6, 12, 24, 48 and 72 hours post surgery
Secondary	Patient Satisfaction as Assessed by Likert Scale	Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn.; Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).	48 hours post surgery
Secondary	Patient Satisfaction as Assessed by Likert Scale	Patient reported a score for each of 4 different aspects of satisfaction: their quality of sleep, ability to ambulate, ability to breast or formula feed, and ability to feed and take care of newborn.; Each of the 4 aspects of satisfaction were rated on a 5-point Likert scale as follows: Extremely satisfied (5), Very satisfied (4), Moderately satisfied (3), Slightly satisfied (2), Not satisfied (1).	72 hours post surgery
Secondary	Time to First Analgesic Request		72 hours post surgery