Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Analgesics, Opioid Clinical Trial

Official title:

Rescue Quadratus Lumborum Blocks for Post-cesarean Pain

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04397458
• Other study ID #: HSC-MS-20-0124
• Status: Withdrawn
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: June 30, 2022

Study information

• Verified date: November 2023
• 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 assess whether quadratus lumborum (QL) block performed 1 day after cesarean delivery will provide supplemental post-cesarean analgesia and reduce opioid requirements.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• elective or non-elective cesarean delivery on prior day
• pain scores >5/10

Exclusion Criteria:

• BMI >40
• obstructive sleep apnea
• drug abuse
• chronic pain
• chronic opioid use
• abdominal surgeries other than cesarean delivery
• contraindications to neuraxial or regional anesthesia
• received general anesthesia or did not receive neuraxial morphine for cesarean delivery

Related Conditions & MeSH terms

• Analgesics
• Analgesics, Opioid
• Morphine
• Peripheral Nervous System Agents

Intervention

Drug:
• Saline
0.9% saline on each side
• Bupivacaine
0.25% bupivacaine (50mg) on each side
• Dexamethasone
3mg preservative-free dexamethasone on each side

Locations

Country	Name	City	State
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 opioid consumption		48 hours after intervention
Secondary	Amount of opioids used		at the time of intervention (one day following cesarean delivery)
Secondary	Amount of opioids used		6 hours after intervention
Secondary	Amount of opioids used		12 hours after intervention
Secondary	Amount of opioids used		24 hours after intervention
Secondary	Amount of opioids used		48 hours after intervention
Secondary	Time from quadratus lumborum block until first opioid request		from time of intervention until time of first opioid request (up to 48 hours)
Secondary	Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	at the time of intervention (one day following cesarean delivery)
Secondary	Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	at the time of intervention (one day following cesarean delivery)
Secondary	Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	6 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	6 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	12 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	12 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	24 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	24 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (at rest)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	48 hours after intervention
Secondary	Pain as measured by an 11-point verbal pain score (with movement)	The 11-point verbal pain score ranges from 0-10, with a higher number indicating worse pain.	48 hours after intervention
Secondary	Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Secondary	Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Secondary	Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Secondary	Nausea, pruritus and sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Secondary	Nausea as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Secondary	Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Secondary	Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Secondary	Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Secondary	Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Secondary	Pruritus as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Secondary	Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	at the time of intervention (one day following cesarean delivery)
Secondary	Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	6 hours after intervention
Secondary	Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	12 hours after intervention
Secondary	Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	24 hours after intervention
Secondary	Sedation as measured by a 3-point scale	This is measured categorically as none, mild, or moderate-severe.	48 hours after intervention
Secondary	Patient satisfaction as measured by the 5-point Likert scale	The 5-point scale ranges from extremely satisfied to not satisfied.	48 hours after intervention