Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section (QLB)
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|ClinicalTrials.gov Identifier: NCT03428880|
Recruitment Status : Completed
First Posted : February 12, 2018
Last Update Posted : February 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Block||Drug: Morphine Drug: Quadratus lumborum block||Phase 4|
In this prospective double blinded randomized study,120 parturients undergoing cesarian delivery via a Pfannenstiel incision and who agreed to spinal anesthesia were randomly scheduled to receive either a SAM (group SAM, n=60) or a Quadratus lumborum block type 3 (group QLB, n=60).Spinal anesthesia was initiated with hyperbaric Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 0.1 mg morphine in the SAM group and with Bupivacaïne 0.5% 10 mg, 0,005 mg SUFENTANIL MEDIS and 1 ml normal saline in group QLB.
After surgery, bilateral QLB block type 3 was performed with the patient in lateral position using bupivacaine 0.25% , 20 mL on each side in group QLB and 20 ml normal saline in group SAM.
Postoperative analgesia for the first 24 hours consisted of a patient controlled analgesia with IV morphine only. If necessary breakthrough pain was treated by 01 g paracetamol intravenously by the same doctor in charge of taking the values of the visual analogue scale.
Patients were assessed postoperatively in the postanesthesia care unit (time 0 hours) and at 2, 4, 6, 12 and 24 hours.
Visual analogue scale (VAS) for pain at rest and during the palpation of the uterine globe was noted.
The primary outcome measure was the total dose of morphine over 24 hours delivered by a patient-controlled analgesia system at predetermined intervals.
Secondary outcomes were visual analogue scale (VAS) for pain at rest and on the palpation of the uterine globe ,heart rate, blood pressure, itching, nausea, pruritus, vomiting and sedation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery|
|Actual Study Start Date :||February 15, 2017|
|Actual Primary Completion Date :||September 30, 2017|
|Actual Study Completion Date :||October 20, 2017|
Active Comparator: spinal morphine
intrathecal morphine with 10 mg bupivacaine, 5 gamma sufenta and 100 gamma morphine. Intervention: In the end of surgery a QLB block is done with 20 ml of normal saline per side.
spinal morphine is done before cesarean section
Other Name: spinal morphine
Active Comparator: quadratus lumborum block
intrathecal anesthesia with10 mg bupivacaine, 5 gamma sufena and 1 ml normal saline.
Procedure : a quadratus lumborum block is done with 20 ml of bupivacaine 0,125% per side.
Drug: Quadratus lumborum block
a US Block QLB is done after surgery
Other Name: QLB
- Total morphine consumption over 24 hours postoperatively [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.
- Time to first analgesic demand using PCA pump with morphine [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]recording the exact time to first analgesic demand by using the PCA with Morphine
- Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]At predetermined intervalls, visual analog scale (VAS) pain scores at rest and at the palpation of the uterine globe were noted.
- Time to first deambulaton after surgery [ Time Frame: Arrival to post anesthesia care unit until 24 hours posteratively ]After surgery, time when the patient was able to move from bed was noted.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03428880
|Tunis maternity and neonatology center, minisetry of public health|
|Tunis, Tunisia, 1007|
|Tunis maternity and neonatology center,|
|Tunis, Tunisia, 1007|
|Study Chair:||Hayene Maghrebi, Professor||tunis maternity center|