Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries

Effect of Adding Magnesium Sulphate as an Adjuvant to Bupivacaine in Ultrasound-guided Quadratus Lumborum Block for Postoperative Analgesia in Lower Abdominal Cancer Surgeries.

The aim of this study is to assess the efficacy of Mg sulfate ( 10% ) as an adjuvant to Bupivacain ( 0.25 % ) in an U.S guided QLB for postoperative analgesia and postoperative Morphine consumption in lower abdominal cancer surgeries.

Study Overview

• Status: Not yet recruiting
• Conditions: QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia
• Intervention / Treatment: Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries

Detailed Description

It is vital to apply adequate postoperative analgesia following lower abdominal surgeries of cancer because Postoperative pain not only affects the patients' rest but also produces a series of pathological reactions. Postoperative analgesia, including regional anesthesia, is very important which not only provides effective postoperative analgesia but also reduces the need for postoperative opioids.In recent years, various ultrasound-guided regional anethetic techniques have been extensively used. One of them is Quadratus lumborum block which can provide postoperative analgesia of the segmental innervation from T6 to L1. In which the Local anesthetics can spread through the thoracolumbar fascia to the paravertebral space, thereby blocking part of the sympathetic nerves . Clinical studies have shown that compared with the current widely used transverse abdominal block, QLB provides longer analgesia and wider block levels when the same dose of local anesthetic is used unlike traditional trunk block, QLB cannot use the sense of falling during puncture and can only be performed under ultrasound guidance, which has the advantages of being real-time and dynamic. Ultrasound-guided nerve block provides more accurate positioning and benefits for patients with less injury. Magnesium sulfate plays an important role in the physiological function of the human body. A large number of studies have reported the safety and effectiveness of adding magnesium sulfate as an adjuvant in various regional anethetic techniques . Therefore, we designed a prospective randomized controlled trial to compare the analgesic efficacy of combining magnesium sulfate with bupivacaine in QLB.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martha Aweda, Resedent dr; Phone Number: 01201538885; Email: marthaweda@gmail.com
• Study Contact Backup: Name: Moaaz Tohamy, Doctor; Phone Number: 01062119486; Email: Moaaz670@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age from 18 to 80 years old
2. Both gender
3. Weight from 55 to 85 kg
4. ASA groups 2 and 3
5. Lower abdominal cancer surgeries

Exclusion Criteria:

• 1. Patient refusal 2. True local anesthetic allergy 3. Coagulopathy 4. Local infection at the procedure site 5. Psychic patients 6. Patient on chronic opioid use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; receive pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine on each side of the abdominal wall before induction of GA.	Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries; Bilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle
Experimental: InterventionalGroup; received pre-emptive ultrasound-guided quadratus lumborum block with 25 mL of 0.25% bupivacaine plus 2 ml of magnesium sulfate 10 % on each side of the abdominal wall before induction of GA.	Drug: Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries; Bilateral ultrasound-guided transmuscular (anterior) quadratus lumborum block will be performed Each patient will be placed in the lateral position. the transducer will be placed in a transverse orientation on the flank just cranial to the iliac crest, then slide posteriorly to obtain an image of the quadratus lumborum muscle.echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle; the correct position of the needle tip will be confirmed by injecting 3 mL of saline to separate the fascial layers at the lateral aspect of the quadratus lumborum muscle. Thereafter, the needle will be advanced more posteriorly between the quadratus muscle and psoas major muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesia	Total morphine consumption during first 24hr postoperative	First 24 hrs postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Pelausa EO. Otolaryngology in Atlantic Canada: practitioners' perspectives. J Otolaryngol. 1999 Feb;28(1):31-6.
• Mintz S, Anavi Y, Sabes WR. Peripheral ameloblastoma of the gingiva. A case report. J Periodontol. 1990 Oct;61(10):649-52. doi: 10.1902/jop.1990.61.10.649.
• Smith BE, Suchak M, Siggins D, Challands J. Rectus sheath block for diagnostic laparoscopy. Anaesthesia. 1988 Nov;43(11):947-8. doi: 10.1111/j.1365-2044.1988.tb05658.x.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Abdominal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: Quadratus lumborum block

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No