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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04397458
Other study ID # HSC-MS-20-0124
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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