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

NCT05397236 | Completed

• 1 other identifier: FMASU MS 256/2021
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Duration of post-operative analgesia

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

  24hours

Secondary Outcomes (11)

• Mean arterial blood pressure

  24 hours

• Heart rate

  24 hours

• The severity of post-operative pain at rest

  24 hours

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

  24 hours

• Number of patients requiring post-operative rescue analgesia

  24 hours

Study Arms (3)

Bupivacaine Magnesium sulphate group

ACTIVE COMPARATOR

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

Drug: Bupivacaine- Magnesium

Bupivacaine Dexamethasone group

ACTIVE COMPARATOR

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

bupivacaine saline group

ACTIVE COMPARATOR

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

Drug: Bupivacaine saline

Interventions

Bupivacaine- Magnesium DRUG

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

Bupivacaine Magnesium sulphate group

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 Dexamethasone group

Bupivacaine saline DRUG

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

bupivacaine saline group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain-Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: May 31, 2022
• Study Start: June 1, 2021
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)