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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05397236
Collaborator
(none)
66
1
3
8
8.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine- Magnesium
  • Drug: Bupivacaine dexamethasone
  • Drug: Bupivacaine saline
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jun 1, 2021
Actual Primary Completion Date :
Feb 1, 2022
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Duration of post-operative analgesia [24hours]

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

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. Number of patients requiring post-operative rescue analgesia [24 hours]

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

  6. Total dose of pethidine given [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: [24 hours]

    Number of patients who develop nausea and/or vomitting

  8. Time to first ambulation [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 [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 [24 hours]

    number of patients who develop lower limb weakness

  11. Local Anesthetic Systemic Toxicity (LAST): [24 hours]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain-Shams University Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ghada M.Samir, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05397236
Other Study ID Numbers:
  • FMASU MS 256/2021
First Posted:
May 31, 2022
Last Update Posted:
May 31, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 31, 2022