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Clinical Trials/NCT05397236
NCT05397236
Completed
Not Applicable

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

Ain Shams University1 site in 1 country66 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Bupivacaine- Magnesium
Conditions
Post Operative Pain
Sponsor
Ain Shams University
Enrollment
66
Locations
1
Primary Endpoint
Duration of post-operative analgesia
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
February 1, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ghada M.Samir

Assistant Professor

Ain Shams University

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

Arms & Interventions

Bupivacaine Magnesium sulphate group

Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.

Intervention: Bupivacaine- Magnesium

Bupivacaine Dexamethasone group

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.

Intervention: Bupivacaine dexamethasone

bupivacaine saline group

Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

Intervention: Bupivacaine saline

Outcomes

Primary Outcomes

Duration of post-operative analgesia

Time Frame: 24hours

Time from completion of the block to the first request of rescue analgesia.

Secondary Outcomes

  • Mean arterial blood pressure(24 hours)
  • Heart rate(24 hours)
  • The severity of post-operative pain at rest(24 hours)
  • The severity of post-operative pain with movement (bilateral knee flexion)(24 hours)
  • Number of patients requiring post-operative rescue analgesia(24 hours)
  • Total dose of pethidine given(24 hours)
  • Occurrence of nausea and/or vomiting:(24 hours)
  • Time to first ambulation(24 hours)
  • The analgesic satisfaction at 24 post-operative hours(24 hours)
  • Inadvertent femoral nerve block(24 hours)
  • Local Anesthetic Systemic Toxicity (LAST):(24 hours)

Study Sites (1)

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