Skip to main content
OpenTrials
Completed

NCT Number: NCT04000308

QLB vs. Wound Infiltration in Cesarean Section

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMC Ljubljana

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. Total amount of piritramide used in first 24 hours

    Time frame: 24 hours post CS

    Total amount of piritramide administered in the first 24 hours after CS

Secondary outcomes

  1. Total amount of piritramide used in first 48 hours

    Time frame: 48 hours post CS

    Total amount of piritramide administered in the first 48 hours after CS

  2. Numerical rating scale (0-10) at rest

    Time frame: Within 48 hours post CS

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  3. Numerical rating scale (0-10) with movement

    Time frame: Within 48 hours post CS

    The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).

  4. Ramsay scale

    Time frame: within 24 hours post CS

    Ramsay scale measures level of sedation: 1 Patient is anxious and agitated or restless, or both. 2 Patient is co-operative, oriented, and tranquil. 3 Patient responds to commands only. 4 Patient exhibits brisk response to light glabellar tap or loud auditory stimulus.

  5. Itching

    Time frame: within 24 hours post CS

    Itching will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe

  6. Nausea

    Time frame: within 24 hours post CS

    Nausea will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe or vomiting

  7. Surgery-to-first-ambulation time

    Time frame: within 48 hours post CS

    Time from surgery to first ambulation of the patient

  8. Surgery-to-breast-feeding time

    Time frame: within 48 hours post CS

    Time from surgery to first breast-feeding

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Quadratus Lumborum Block Type 2 Versus Wound Infiltration in Cesarean Section: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 27, 2019
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.