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

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

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.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Bupivacaine- Magnesium; Drug: Bupivacaine dexamethasone; Drug: Bupivacaine saline

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain-Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine Magnesium sulphate group; Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.	Drug: Bupivacaine- Magnesium; Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
Active Comparator: 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.	Drug: 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.
Active Comparator: bupivacaine saline group; Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.	Drug: Bupivacaine saline; Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): February 1, 2022
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: FMASU MS 256/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No