Clinical trial NCT05397236: Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
Official title: A Comparative Study Between the Effect of Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.

This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status I or II
* aged 18 to 65 years
* body weight ≥ 60 kg and ≤ 90 kg
* scheduled for open abdominal surgeries

Exclusion Criteria:

* Patients' refusal to participate in the study
* history of allergy to the medications used in the study
* hepatic disease
* renal disease
* known neurologic disorders
* psychiatric disorder
* chronic treatment with calcium channel blockers
* hyper-magnesemia
* coagulopathy
* anatomical abnormalities
* hemodynamic instability
* local infection
* suspected intra- abdominal sepsis

Primary outcomes:
measure: Duration of post-operative analgesia
timeFrame: 24hours
Secondary outcomes:
measure: Mean arterial blood pressure
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
measure: The severity of post-operative pain at rest
timeFrame: 24 hours
measure: The severity of post-operative pain with movement (bilateral knee flexion)
timeFrame: 24 hours
measure: Number of patients requiring post-operative rescue analgesia
timeFrame: 24 hours
measure: Total dose of pethidine given
timeFrame: 24 hours
measure: Occurrence of nausea and/or vomiting:
timeFrame: 24 hours
measure: Time to first ambulation
timeFrame: 24 hours
measure: The analgesic satisfaction at 24 post-operative hours
timeFrame: 24 hours
measure: Inadvertent femoral nerve block
timeFrame: 24 hours
measure: Local Anesthetic Systemic Toxicity (LAST):
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University
Study officials:
References: