NCT04000308|Completed
QLB vs. Wound Infiltration in Cesarean Section
Quadratus Lumborum Block Type 2 Versus Wound Infiltration in Cesarean Section: a Randomized Controlled Trial
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Quadratus Lumborum Block Type 2 Versus Wound Infiltration in Cesarean Section: a Randomized Controlled Trial
Sponsor study identifier
interventional
116
1 country
1
Study Start
August 28, 2019
Actual (reported)Primary Completion
May 12, 2020
Actual (reported)Study Completion
May 12, 2020
Actual (reported)Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. A 2009 Cochrane review concluded that wound infiltration with local analgesic after CS reduced opioid consumption. In addition, two regional anesthetic techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum block (QLB), have been shown in multiple studies to reduce post-operative opioid consumption after CS. A recent randomized controlled trial showed that QLB is more effective in reducing morphine consumption post-CS compared to TAP. No randomized controlled trial to date, however, compared the analgesic effect of QLB with infiltration of the wound after CS. The objective of the study is to compare the analgesic effect of QLB type 2 with wound infiltration after CS.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 12, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 24, 2019
Actual (reported)June 27, 2019
Actual (reported)August 28, 2019
Actual (reported)May 12, 2020
Actual (reported)May 12, 2020
Actual (reported)Total amount of piritramide used in first 24 hours
Total amount of piritramide administered in the first 24 hours after CS
24 hours post CS
Total amount of piritramide used in first 48 hours
48 hours post CS
Numerical rating scale (0-10) at rest
Within 48 hours post CS
Numerical rating scale (0-10) with movement
Within 48 hours post CS
Ramsay scale
within 24 hours post CS
Itching
within 24 hours post CS
The obstetrician (multiple, experienced clinicians) will infiltrate the wound (Pfannenstiel incision) subcutaneously at the end of surgery with 20 ml normal saline. Subsequently, a US-guided QLB using a linear/convex transducer will be performed by the anesthesiologist using 30 ml levobupivacaine 0.18% (20 ml 0.25% levobupivacaine + 10 ml normal saline) bilaterally (60 ml in total).
Patricipants will receive 20 ml levobupivacaine 0.25% infiltration in the surgical wound and US-guided QLB with 30 ml normal saline bilaterally (60 ml in total).
The obstetrician (multiple, experienced clinicians) will infiltrate the wound (Pfannenstiel incision) subcutaneously at the end of surgery with 20 ml normal saline. Subsequently, a US-guided QLB using a linear/convex transducer will be performed by the anesthesiologist using 30 ml levobupivacaine 0.18% (20 ml 0.25% levobupivacaine + 10 ml normal saline) bilaterally (60 ml in total).
Participants will receive 20 ml levobupivacaine 0.25% infiltration in the surgical wound and US-guided QLB with 30 ml normal saline bilaterally (60 ml in total).
UMC Ljubljana
Ljubljana, 1000, Slovenia
Stopar-Pintaric T, Blajic I, Visic U, Znider M, Plesnicar A, Vlassakov K, Lucovnik M. Posteromedial quadratus lumborum block versus wound infiltration after caesarean section: A randomised, double-blind, controlled study. Eur J Anaesthesiol. 2021 Aug 1;38(Suppl 2):S138-S144. doi: 10.1097/EJA.0000000000001531.
116 participants (actual enrollment reported by the registry).
First Submitted
June 24, 2019
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
First Posted
June 27, 2019
Study Start
August 28, 2019
Actual (reported)Primary Completion
May 12, 2020
Actual (reported)Study Completion
May 12, 2020
Actual (reported)Last Updated
May 15, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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