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Trial Title:
Role of Magnesium Sulphate as an Adjuvant to Bupivacaine in U.S Guided Quadratus Lumborum Block in Lower Abdominal Cancer Surgeries
NCT ID:
NCT06301789
Condition:
QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia
Conditions: Official terms:
Abdominal Neoplasms
Bupivacaine
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Effect of adding Mg sulphate as an adjuvant to bupivacaine for postoperative analgesia in
cases of lower abdominal cancer surgeries
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries
Description:
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
Arm group label:
Control Group
Arm group label:
InterventionalGroup
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
Accepts Healthy Volunteers
Start date:
April 2024
Completion date:
March 2026
Lead sponsor:
Agency:
Assiut University
Agency class:
Other
Source:
Assiut University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06301789
