Clinical trial NCT04000308: QLB vs. Wound Infiltration in Cesarean Section
Official title: Quadratus Lumborum Block Type 2 Versus Wound Infiltration in Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Cesarean Section
Keywords: Analgesia
Cesarean Section
Quadratus Lumborum Block type 2
Wound Infiltration
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2019-06-27
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized, double-blind trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Effective postoperative analgesia after cesarean section (CS) is important because it enables early ambulation and facilitates breast-feeding. Post-CS analgesia is usually multimodal. At our hospital, patients are routinely given a combination of parenteral paracetamol, metamizole and tramadol at fixed intervals with additional intravenous piritramide on demand. The well-known side effects of piritramide (nausea, vomiting, and sedation) may interfere with interaction between mother and child, breast-feeding and post-partum experience in a dose-dependent manner. Alternative strategies to reduce rescue opioid analgesic consumption post-CS section are, therefore, required.

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.

Telnes et al. compared TAP block with wound infiltration with local anesthetic following CS. They found no reduction in cumulative morphine consumption and more pronounced sedation associated with TAP block. 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.

Eligibility criteria: Inclusion Criteria:

* Parturients scheduled for an elective caesarean delivery under spinal anaesthesia with an American Society of Anesthesiologists physical status I or II, singleton pregnancy, and gestational age ≥ 37 completed weeks.

Exclusion Criteria:

* Congenital or acquired coagulopathy.
* Allergy to local anaesthetics.
* History of drug abuse.

Primary outcomes:
measure: Total amount of piritramide used in first 24 hours
timeFrame: 24 hours post CS
Secondary outcomes:
measure: Total amount of piritramide used in first 48 hours
timeFrame: 48 hours post CS
measure: Numerical rating scale (0-10) at rest
timeFrame: Within 48 hours post CS
measure: Numerical rating scale (0-10) with movement
timeFrame: Within 48 hours post CS
measure: Ramsay scale
timeFrame: within 24 hours post CS
measure: Itching
timeFrame: within 24 hours post CS
measure: Nausea
timeFrame: within 24 hours post CS
measure: Surgery-to-first-ambulation time
timeFrame: within 48 hours post CS
measure: Surgery-to-breast-feeding time
timeFrame: within 48 hours post CS
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
References:
citation: 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.