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

Post Operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397236
• Other study ID #: FMASU MS 256/2021
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: May 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 1, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Bupivacaine- Magnesium
Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
• 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.
• Bupivacaine saline
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.

Locations

Country	Name	City	State
Egypt	Ain-Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of post-operative analgesia	Time from completion of the block to the first request of rescue analgesia.	24hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients requiring post-operative rescue analgesia	Number of patients requiring pethidine in the 24 hours post-operative period	24 hours
Secondary	Total dose of pethidine given	The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.	24 hours
Secondary	Occurrence of nausea and/or vomiting:	Number of patients who develop nausea and/or vomitting	24 hours
Secondary	Time to first ambulation	The time to the start of movement by each patient in the 24 hours post-operative period	24 hours
Secondary	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
Secondary	Inadvertent femoral nerve block	number of patients who develop lower limb weakness	24 hours
Secondary	Local Anesthetic Systemic Toxicity (LAST):	As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.	24 hours