Comparative Study Between the Analgesic Effect of Dexmedetomidine and Magnesium Sulfate As Adjuvant to Bupivacaine Using Ultrasound-Guided Transversus Abdominis Plane Block in Abdominal Hysterectomy : a Randomized Double-blinded Study

NCT ID: NCT06720337

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-02-01

Brief Summary

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Over 80% of patients who undergo surgery suffer from acute postoperative pain, with 75% of them rating the pain severity as moderate, severe, or extreme. Studies have shown that less than 50% of patients who undergo surgery report adequate relief from postoperative pain.

Additionally, if pain is not promptly managed after surgery, it can hinder a patient's ability to walk, potentially causing adverse effects such as thromboembolism, myocardial ischemia, and arrhythmia.

The opioid analgesics are most commonly used as parenteral agents to manage post operative pain but the problem of respiratory depression remains to be considered.

This study is designed to compare the analgesic effect between dexmedetomidine versus magnesium sulfate as adjuvant to bupivacaine using ultrasound guided Transversus Abdominis Plane block in patients undergoing abdominal hysterectomy

Detailed Description

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In addition to parenteral opioids and NSAIDS, various other methods used for post operative analgesia are infiltration of local anaesthetic agents, dermal patches, patient-controlled analgesia and epidural catheters, etc.

Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. In order to achieve the best pain treatment, many ERPs use a multimodal approach, decreasing the use of opioids as the primary analgesic in Favor of neuraxial and regional anaesthetic techniques.

One of the regional techniques routinely used is the transversus abdominis plane (TAP) block. Its widespread use in abdominal surgeries is due to its technical simplicity and trustworthy analgesia.

Conditions

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Hysterectomy

Keywords

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ultrasound-Guided Transversus Abdominis Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Patients will be randomly allocated into one of the two study designed groups using computer-generated random numbers table.

Study Groups

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group A

Patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side

Group Type EXPERIMENTAL

bupivacaine 0.5%

Intervention Type DRUG

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) using Ultrasound-Guided TAP Block Technique

Dexmedetomidine

Intervention Type DRUG

patients will receive plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side

group b

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side

Group Type EXPERIMENTAL

bupivacaine 0.5%

Intervention Type DRUG

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) using Ultrasound-Guided TAP Block Technique

MgSO4

Intervention Type DRUG

patients will receive plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side

Interventions

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bupivacaine 0.5%

patients will receive 18 ml 0.5% bupivacaine (Sunnypivacaine®) using Ultrasound-Guided TAP Block Technique

Intervention Type DRUG

Dexmedetomidine

patients will receive plus 0.5 µg/kg of dexmedetomidine (Precedex® 100 µg/ml) diluted in 2 ml of normal saline at each side

Intervention Type DRUG

MgSO4

patients will receive plus 1.5 mL (150 mg) MgSO4 and 0.5 mL normal saline at each side

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA classification I-ll,
* Aged \>18 years,
* weight 50-85 kg,
* Patients who will undergo total abdominal hysterectomy

Exclusion Criteria

* • ASA classification I-ll,

* Aged \>18 years,
* weight 50-85 kg,
* Patients who will undergo total abdominal hysterectomy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Abdelrahman Mahfouz Ali

resident doctor at Anaesthesia, Intensive Care and Pain Management department Faculty of Medicine, Assiut University

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Abdelrahman Mahfouz Ali, resident doctor

Role: CONTACT

Phone: +2 01023864487

Email: [email protected]

References

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Yu N, Long X, Lujan-Hernandez JR, Succar J, Xin X, Wang X. Transversus abdominis-plane block versus local anesthetic wound infiltration in lower abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2014 Dec 15;14:121. doi: 10.1186/1471-2253-14-121. eCollection 2014.

Reference Type BACKGROUND
PMID: 25580086 (View on PubMed)

Other Identifiers

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Dexmedetomidine and Mgso4 TAP

Identifier Type: -

Identifier Source: org_study_id