QLB vs. Wound Infiltration in Cesarean Section
- Conditions
- Cesarean SectionAnalgesia
- Interventions
- Drug: Wound InfiltrationDrug: Quadratus Lumborum Block type 2
- Registration Number
- NCT04000308
- Lead Sponsor
- University Medical Centre Ljubljana
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 116
- 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.
- Congenital or acquired coagulopathy.
- Allergy to local anaesthetics.
- History of drug abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Wound Infiltration 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). Quadratus Lumborum Block type 2 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).
- Primary Outcome Measures
Name Time Method Total amount of piritramide used in first 24 hours 24 hours post CS Total amount of piritramide administered in the first 24 hours after CS
- Secondary Outcome Measures
Name Time Method Ramsay scale 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.
Itching within 24 hours post CS Itching will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe
Numerical rating scale (0-10) at rest 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).
Nausea within 24 hours post CS Nausea will be assessed as following: 0, none; 1, mild; 2, moderate; and 3, severe or vomiting
Total amount of piritramide used in first 48 hours 48 hours post CS Total amount of piritramide administered in the first 48 hours after CS
Numerical rating scale (0-10) with movement 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).
Surgery-to-first-ambulation time within 48 hours post CS Time from surgery to first ambulation of the patient
Surgery-to-breast-feeding time within 48 hours post CS Time from surgery to first breast-feeding
Trial Locations
- Locations (1)
UMC Ljubljana
🇸🇮Ljubljana, Slovenia