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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine- Magnesium
Bupivacaine dexamethasone
Bupivacaine saline
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Bupivacaine Magnesium sulphate group

Bupivacaine Dexamethasone group

bupivacaine saline group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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
Number of patients requiring post-operative rescue analgesia
Number of patients requiring pethidine in the 24 hours post-operative period
Total dose of pethidine given
The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.
Occurrence of nausea and/or vomiting:
Number of patients who develop nausea and/or vomitting
Time to first ambulation
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
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
number of patients who develop lower limb weakness
Local Anesthetic Systemic Toxicity (LAST):
As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.

Full Information

First Posted
May 23, 2022
Last Updated
May 25, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05397236
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine Magnesium sulphate group
Arm Type
Active Comparator
Arm Description
Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
Arm Title
Bupivacaine Dexamethasone group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
bupivacaine saline group
Arm Type
Active Comparator
Arm Description
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine- Magnesium
Intervention Description
Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine dexamethasone
Intervention Description
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 Type
Drug
Intervention Name(s)
Bupivacaine saline
Intervention Description
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
Primary Outcome Measure Information:
Title
Duration of post-operative analgesia
Description
Time from completion of the block to the first request of rescue analgesia.
Time Frame
24hours
Secondary Outcome Measure Information:
Title
Mean arterial blood pressure
Description
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.
Time Frame
24 hours
Title
Heart rate
Description
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.
Time Frame
24 hours
Title
The severity of post-operative pain at rest
Description
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.
Time Frame
24 hours
Title
The severity of post-operative pain with movement (bilateral knee flexion)
Description
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
Time Frame
24 hours
Title
Number of patients requiring post-operative rescue analgesia
Description
Number of patients requiring pethidine in the 24 hours post-operative period
Time Frame
24 hours
Title
Total dose of pethidine given
Description
The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.
Time Frame
24 hours
Title
Occurrence of nausea and/or vomiting:
Description
Number of patients who develop nausea and/or vomitting
Time Frame
24 hours
Title
Time to first ambulation
Description
The time to the start of movement by each patient in the 24 hours post-operative period
Time Frame
24 hours
Title
The analgesic satisfaction at 24 post-operative hours
Description
Patients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
Time Frame
24 hours
Title
Inadvertent femoral nerve block
Description
number of patients who develop lower limb weakness
Time Frame
24 hours
Title
Local Anesthetic Systemic Toxicity (LAST):
Description
As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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

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