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

Not Applicable

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Bupivacaine- Magnesium; Drug: Bupivacaine saline; Drug: Bupivacaine dexamethasone

• Registration Number: NCT05397236
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-02-01
• Status Verified: 2022-05
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-25
• Last Update Submitted: 2022-05-25
• Study First Posted: 2022-05-31
• Last Update Posted: 2022-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupivacaine Magnesium sulphate group	Bupivacaine- Magnesium	Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
bupivacaine saline group	Bupivacaine saline	Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
Bupivacaine Dexamethasone group	Bupivacaine dexamethasone	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.

Primary Outcome Measures

Name	Time	Method
Duration of post-operative analgesia	24hours	Time from completion of the block to the first request of rescue analgesia.

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	24 hours	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.
Heart rate	24 hours	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.
The severity of post-operative pain at rest	24 hours	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.
The severity of post-operative pain with movement (bilateral knee flexion)	24 hours	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
Number of patients requiring post-operative rescue analgesia	24 hours	Number of patients requiring pethidine in the 24 hours post-operative period
Total dose of pethidine given	24 hours	The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.
Occurrence of nausea and/or vomiting:	24 hours	Number of patients who develop nausea and/or vomitting
Time to first ambulation	24 hours	The time to the start of movement by each patient in the 24 hours post-operative period
The analgesic satisfaction at 24 post-operative hours	24 hours	Patients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
Inadvertent femoral nerve block	24 hours	number of patients who develop lower limb weakness
Local Anesthetic Systemic Toxicity (LAST):	24 hours	As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.

Trial Locations

Locations (1)

Ain-Shams University; 🇪🇬 Cairo, Egypt