QLB vs. Wound Infiltration in Cesarean Section

NCT04000308 | Completed

• 1 other identifier: 0120-251/2019/4
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Cesarean Section

Keywords

Analgesia; Cesarean Section; Quadratus Lumborum Block type 2; Wound Infiltration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Study Arms (2)

Quadratus Lumborum Block type 2

EXPERIMENTAL

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).

Drug: Quadratus Lumborum Block type 2

Wound Infiltration

ACTIVE COMPARATOR

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).

Drug: Wound Infiltration

Interventions

Quadratus Lumborum Block type 2 DRUG

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).

Quadratus Lumborum Block type 2

Wound Infiltration DRUG

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).

Wound Infiltration

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

UMC Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

• 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.

  PMID: 33988528 DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization will be performed in a 1:1 ratio using a computer generated randomization sequence. A sealed opaque envelope containing the study number will opened by an anesthetist nurse who will not be involved in the study. This anesthetist nurse will prepare the study medication and label the syringes with a unique study number which will be used to identify the study medication and will be revealed only on completion of data collection at the end of the study. The anesthetists, obstetricians, nurses who will be involved in the study, parturients, and other healthcare providers who will be involved in postoperative care will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: Single-center, randomized, double-blind trial

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: June 27, 2019
• Study Start: August 28, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: May 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)