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Completed

NCT Number: NCT03428880

Ultrasound Guided QLB III Versus Intrathecal Morphine for Analgesia After Cesarean Section

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Tunis maternity and neonatology center,, Tunis, Tunisia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I/II.
  • Normal singleton pregnancy with a gestation of at least 37 weeks.

Exclusion criteria

  • Heart disease
  • Coagulopathy
  • pre-eclampsia
  • BMI> 40
  • Patient refusal to undergo the Quadratus lumborum block.
  • Allergy to local anesthetics

Treatment and study plan

Morphine

Drug

spinal morphine is done before cesarean section

Other names: spinal morphine

Quadratus lumborum block

Drug

a US Block QLB is done after surgery

Other names: QLB

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

Ultrasound Guided Quadratus Lumborum Type III Block Versus Intrathecal Morphine for Analgesia After Cesarean Delivery

Acronym: QLB

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 12, 2018
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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