Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics
NCT ID: NCT05643846
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
196 participants
INTERVENTIONAL
2023-02-27
2025-12-06
Brief Summary
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Many studies have shown that the inclusion of quadratus lumborum block to a multimodal analgesic regimen would reduce pain scores, opioid consumption, and prolonging time to first rescue analgesic after cesarean delivery.
However, the dose and concentration of the local anesthetic used among the studies are varied, and literature search identified no randomized controlled trial which looked at the concentration -response of local anesthetic to optimize the concentration resulting in the best pain relief.
It is a perspective randomized controlled trial to compare the analgesic efficacy of 2 different concentrations of Bupivacaine to standardize postoperative analgesic protocol used for QLB after caesarean section.
Detailed Description
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A written, informed consent is discussed with and signed by all participants, and the participants are randomly assigned into one of two groups; (Group 1) to receive bilateral QLB with '0.125% bupivacaine 0.2 ml/ kg', (Group 2) to receive bilateral QLB with '0.25% bupivacaine 0.2 ml/kg'. For all participants, spinal anesthesia is performed with ultrasonography guidance in a standardized manner using hyperbaric bupivacaine 15mg and fentanyl 25 μg.
At the end of the procedure in the supine position, all participants receive bilateral QLBs performs under ultrasound guidance and aseptic technique. The internal oblique muscle is identified and followed laterally to the lateral interfacial triangle sitting above the quadratus lumborum muscle.
Results will be reported as
1. Total number of PCA morphine demands and the actual doses delivered at predetermined time intervals (1h, 2 h, 4h, 6 h, 12 h, 24 h and 48 h) after surgery
2. Record of supplemental and regular analgesics.
3. Visual analogue score for pain at rest (static) and with movement (dynamic) (defined as the elevation of the head and shoulders off the pillow from the supine position), (0, no pain; 10, worst pain imaginable).
4. Residual nerve block (the time to mobilization)
5. Block-related complications (i.e., hematoma, organ injury, local anesthetic systemic toxicity, and sepsis).
6- Opioids-related side effects (Nausea, Vomiting, Itching)
The investigators hypothesized that using a higher concentration (0.25%) of local anesthetic (Bupivacaine) would increase the analgesic effect without increasing the side effects and complications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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(Group 1) will receive the intervention 'Bupivacaine at concentration of 0.125%, dose of 0.2 ml/kg'.
(Group 1) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at concentration of 0.125% concentration, at a dose of 0.2 ml/kg'.
QLB procedure after cesarean section
Bupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg.
(Group 2) will receive the intervention 'Bupivacaine concentration of 0.25%, dose of 0.2 ml/kg'.
(Group 2) will receive bilateral QLB procedure with the intervention 'Bupivacaine local anesthetic drug at a concentration of 0.25% concentration, at a dose of 0.2 ml/kg'.
QLB procedure after cesarean section
Bupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg.
Interventions
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QLB procedure after cesarean section
Bupivacaine local anesthetic drug used for QLB procedure after Cesarean section. Intervention of two different concentration of Bupivacaine, 0.125% or 0.25%, at a dose of 0.2 ml/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have singleton pregnancy at a gestation of at least 37 weeks.
* Participant who are scheduled for elective caesarean section under spinal anesthesia.
* Participants who are consented to be enrolled into the study.
Exclusion Criteria
* Who have Allergy or sensitivity to study medications.
* Who have anatomical abnormalities or localized infection.
* Who have history of chronic pain or on regular opioids use.
* Who are unable to comprehend or unable to use the verbal rating pain scoring system,
* Failed spinal anesthesia or conversion to general anesthesia after spinal anesthesia.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Danat Al Emarat Hospital
OTHER
Responsible Party
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JINAN AHMED JAMEEL AL ALOOSI
Principle Investigator
Locations
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Danat Al Emarat hospital
Abu Dhabi, , United Arab Emirates
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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RP DAE/2022/102
Identifier Type: -
Identifier Source: org_study_id