QLB vs. Wound Infiltration in Cesarean Section

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

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Cesarean Section
• Intervention / Treatment: Drug: Quadratus Lumborum Block type 2; Drug: Wound Infiltration

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.

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • UMC Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadratus Lumborum Block type 2; 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; 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).
Active Comparator: Wound Infiltration; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total amount of piritramide used in first 48 hours	Total amount of piritramide administered in the first 48 hours after CS	48 hours post CS
Numerical rating scale (0-10) at rest	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).	Within 48 hours post CS
Numerical rating scale (0-10) with movement	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).	Within 48 hours post CS
Ramsay scale	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.	within 24 hours post CS
Itching	Itching will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe	within 24 hours post CS
Nausea	Nausea will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe or vomiting	within 24 hours post CS
Surgery-to-first-ambulation time	Time from surgery to first ambulation of the patient	within 48 hours post CS
Surgery-to-breast-feeding time	Time from surgery to first breast-feeding	within 48 hours post CS

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2019
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 27, 2019

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; Cesarean Section; Quadratus Lumborum Block type 2; Wound Infiltration
• Other Study ID Numbers: 0120-251/2019/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No