A Phase 4 interventional study of Morphine and Quadratus lumborum block in Block, sponsored by University Tunis El Manar. Completed at 2 sites in Tunisia. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-14.
Sponsored by University Tunis El Manar · Phase 4, Interventional, and Treatment
Subarachnoid morphine (SAM) is the gold standard for treating postoperative pain after cesarean delivery (CD) but it has undesirable side effects, that's why the aim of our study is to identify whether ultrasound-guided Quadratus lumborum block type 3, a new regional anesthetic technique that blocks the abdominal wall neural afferents, can provide at the same time better postoperative analgesia after CD with less side effects
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.
Exclusion Criteria:
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.
Drug: Morphine
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
spinal morphine is done before cesarean section
Also known as: spinal morphine
a US Block QLB is done after surgery
Also known as: QLB
Total morphine consumption over 24 hours postoperatively
Total IV morphine used when started postoperatively using a PCA with morphine in the post anesthesia care unit until 2' hours posteratively.
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Time to first analgesic demand using PCA pump with morphine
recording the exact time to first analgesic demand by using the PCA with Morphine
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Visual analog scale (VAS) pain scores at rest and during the palpation of the uterine globe
At predetermined intervalls, visual analog scale (VAS) pain scores at rest and at the palpation of the uterine globe were noted.
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Time to first deambulaton after surgery
After surgery, time when the patient was able to move from bed was noted.
Time frame: Arrival to post anesthesia care unit until 24 hours posteratively
Plan to share: Undecided
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University Tunis El Manar