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Completed

NCT Number: NCT05397236

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.

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain-Shams University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine- Magnesium

Drug

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

Bupivacaine dexamethasone

Drug

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.

Bupivacaine saline

Drug

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

Primary outcomes

  1. Duration of post-operative analgesia

    Time frame: 24hours

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

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: 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.

  2. Heart rate

    Time frame: 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.

  3. The severity of post-operative pain at rest

    Time frame: 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.

  4. The severity of post-operative pain with movement (bilateral knee flexion)

    Time frame: 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

  5. Number of patients requiring post-operative rescue analgesia

    Time frame: 24 hours

    Number of patients requiring pethidine in the 24 hours post-operative period

  6. Total dose of pethidine given

    Time frame: 24 hours

    The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.

  7. Occurrence of nausea and/or vomiting:

    Time frame: 24 hours

    Number of patients who develop nausea and/or vomitting

  8. Time to first ambulation

    Time frame: 24 hours

    The time to the start of movement by each patient in the 24 hours post-operative period

  9. The analgesic satisfaction at 24 post-operative hours

    Time frame: 24 hours

    Patients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent.

  10. Inadvertent femoral nerve block

    Time frame: 24 hours

    number of patients who develop lower limb weakness

  11. Local Anesthetic Systemic Toxicity (LAST):

    Time frame: 24 hours

    As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 31, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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