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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05397236
Enrollment
66
Registered
2022-05-31
Start date
2021-06-01
Completion date
2022-02-01
Last updated
2022-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

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.

Interventions

DRUGBupivacaine- Magnesium

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

DRUGBupivacaine 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.

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of post-operative analgesia24hoursTime from completion of the block to the first request of rescue analgesia.

Secondary

MeasureTime frameDescription
Mean arterial blood pressure24 hoursMeasured 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 rate24 hoursRecorded 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 rest24 hoursBy 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)24 hoursBy 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 analgesia24 hoursNumber of patients requiring pethidine in the 24 hours post-operative period
Local Anesthetic Systemic Toxicity (LAST):24 hoursAs any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.
Occurrence of nausea and/or vomiting:24 hoursNumber of patients who develop nausea and/or vomitting
Time to first ambulation24 hoursThe time to the start of movement by each patient in the 24 hours post-operative period
The analgesic satisfaction at 24 post-operative hours24 hoursPatients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
Inadvertent femoral nerve block24 hoursnumber of patients who develop lower limb weakness
Total dose of pethidine given24 hoursThe cumulative total pethidine doses given to each patient in the 24 hours post-operative period.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026