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

Block Clinical Trial

— QLB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03428880
• Other study ID #: fel-bich
• Status: Completed
• Phase: Phase 4
• First received: February 5, 2018
• Last updated: February 12, 2018
• Start date: February 15, 2017
• Est. completion date: October 20, 2017

Study information

• Verified date: February 2018
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 20, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Block

Intervention

Drug:
• Morphine
spinal morphine is done before cesarean section
• Quadratus lumborum block
a US Block QLB is done after surgery

Locations

Country	Name	City	State
Tunisia	Tunis maternity and neonatology center,	Tunis
Tunisia	Tunis maternity and neonatology center, minisetry of public health	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Arrival to post anesthesia care unit until 24 hours posteratively
Secondary	Time to first analgesic demand using PCA pump with morphine	recording the exact time to first analgesic demand by using the PCA with Morphine	Arrival to post anesthesia care unit until 24 hours posteratively
Secondary	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.	Arrival to post anesthesia care unit until 24 hours posteratively
Secondary	Time to first deambulaton after surgery	After surgery, time when the patient was able to move from bed was noted.	Arrival to post anesthesia care unit until 24 hours posteratively