QLB vs. Wound Infiltration in Cesarean Section

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000308
• Other study ID #: 0120-251/2019/4
• Status: Completed
• Phase: N/A
• Start date: August 28, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: May 2020
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Cesarean Section

Intervention

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).
• 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).

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Itching	Itching will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe	within 24 hours post CS
Secondary	Nausea	Nausea will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe or vomiting	within 24 hours post CS
Secondary	Surgery-to-first-ambulation time	Time from surgery to first ambulation of the patient	within 48 hours post CS
Secondary	Surgery-to-breast-feeding time	Time from surgery to first breast-feeding	within 48 hours post CS