Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block

Study Overview
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Brief Summary
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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.

Official Title
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A Comparative Study Between the Effect of Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Bupivacaine- Magnesium
* Drug: Bupivacaine dexamethasone
* Drug: Bupivacaine saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine Magnesium sulphate group<br>Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4. | Drug: Bupivacaine- Magnesium<br>* Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.<br>|
| Active Comparator: Bupivacaine Dexamethasone group<br>Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS. | Drug: Bupivacaine dexamethasone<br>* Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.<br>|
| Active Comparator: bupivacaine saline group<br>Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS. | Drug: Bupivacaine saline<br>* Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of post-operative analgesia | Time from completion of the block to the first request of rescue analgesia. | 24hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean arterial blood pressure | Measured before induction of anesthesia (base line), upon arrival to the PACU, after 30 and 60 min. If hypotension (MBP < 20% of the base line value) occurred, 3 mg increments of ephedrine repeated every 5 min if required was given. MBP was then recorded at 2, 6, 12 and 24 post-operative hours. | 24 hours | 
| Heart rate | Recorded before induction of anesthesia (base line),upon arrival to the PACU, after 30 and 60 min. If bradycardia (HR <50 bpm) occurred, 0.5 mg atropine was given. HR was then recorded at 2, 6, 12 and 24 post-operative hours. | 24 hours | 
| The severity of post-operative pain at rest | By using the Visual Analogue Scale (VAS); from 0= no pain, to 10=worst imaginable pain. Assessed upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12 and 24 post-operative hours. | 24 hours | 
| The severity of post-operative pain with movement (bilateral knee flexion) | By using the Visual Analogue Scale (VAS); from 0= no pain, to 10=worst imaginable pain. Assessed at 2, 4, 6, 8, 12 and 24 post-operative hours | 24 hours | 
| Number of patients requiring post-operative rescue analgesia | Number of patients requiring pethidine in the 24 hours post-operative period | 24 hours | 
| Total dose of pethidine given | The cumulative total pethidine doses given to each patient in the 24 hours post-operative period. | 24 hours | 
| Occurrence of nausea and/or vomiting: | Number of patients who develop nausea and/or vomitting | 24 hours | 
| Time to first ambulation | The time to the start of movement by each patient in the 24 hours post-operative period | 24 hours | 
| The analgesic satisfaction at 24 post-operative hours | Patients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent. | 24 hours | 
| Inadvertent femoral nerve block | number of patients who develop lower limb weakness | 24 hours | 
| Local Anesthetic Systemic Toxicity (LAST): | As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics. | 24 hours |