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

NCT ID: NCT06301789

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2026-03-31

Brief 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.

Conditions

QLB in Lower Abdominal Cancer Surgeries as a Post Operative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Effect of adding Mg sulfate as an adjuvant to bupivacain in U/S guided QLB for postoperative analgesia in lower abdominal cancer surgeries

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Martha Aweda Soliman

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Martha Aweda, Resedent dr

Role: CONTACT

marthaweda@gmail.com

01201538885

Moaaz Tohamy, Doctor

Role: CONTACT

Moaaz670@gmail.com

01062119486

References

Pelausa EO. Otolaryngology in Atlantic Canada: practitioners' perspectives. J Otolaryngol. 1999 Feb;28(1):31-6.

Reference Type: BACKGROUND

PMID: 10077781 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2231232 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 2975148 (View on PubMed)

Other Identifiers

Quadratus lumborum block

Identifier Type: -

Identifier Source: org_study_id