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Assessment of the Impact of Two Dexmedetomidine Dosages Added with Bupivacaine in Ultrasound-Guided Transversus Abdominis Plane Block for Postoperative Analgesia Following Inguinal Hernia Repair

NCT ID: NCT06703229

Last Updated: 2024-12-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-15

Study Completion Date

2024-11-15

Brief Summary

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The principal outcome assessed was the duration until the initial request for analgesia post-surgery. The secondary outcomes encompassed the total quantity of analgesics administered (ketorolac, paracetamol, and morphine) within the initial 24 hours. Pain levels, measured using the Visual Analogue Scale (VAS), were evaluated at rest and during movement at many intervals following surgery (1, 6, 12, and 24 hours). The study also observed postoperative complications, such as emesis, hypotension, bradycardia, and pruritus.

Detailed Description

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One of the most frequently performed surgical procedures worldwide is the repair of an open inguinal hernia, with a postoperative pain severity of moderate to severe affecting over 60% of patients. Post-surgical analgesia frequently employs a multifaceted approach, incorporating oral pharmacotherapy and regional anesthetic procedures. Opioids are a conventional option for postoperative pain management; nevertheless, their administration is linked to adverse effects such as nausea, vomiting, sleepiness, pruritus, and respiratory depression, which may impede the recovery process. Non-opioid alternatives, however, can improve patient rehabilitation and overall outcomes. The Transversus Abdominis Plane (TAP) block efficiently reduces early postoperative discomfort and decreases narcotic usage, which is a significant advantage for patients undergoing inguinal hernia repair. To alleviate pain in the abdominal wall muscles, peritoneum, and skin, this treatment involves administering a local anesthetic into the space between the transversus abdominis and internal oblique muscles.\]2\[

Conditions

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Spinal Anaesthesia Herniorrhaphy Transversus Abdominis Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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group, D1

group, D1, had a TAP block that included 0.5 µg/kg of dexmedetomidine and bupivacaine

Group Type ACTIVE_COMPARATOR

The Transversus Abdominis Plane (TAP) block

Intervention Type DRUG

or injectate preparation, utilizing ultrasound guidance while the patient was supine. In the D1 group, patients were administered 20 mL of 0.25% isobaric bupivacaine with 0.5 mcg/kg of dexmedetomidine.

group, D2

group, D2, received the same block but with 1 µg/kg of dexmedetomidine.

Group Type ACTIVE_COMPARATOR

The transverse abdominis plane (TAP) block

Intervention Type DRUG

Patients in the D2 group received 20 mL of 0.25% isobaric bupivacaine with 1 mcg/kg of dexmedetomidine.

Interventions

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The Transversus Abdominis Plane (TAP) block

or injectate preparation, utilizing ultrasound guidance while the patient was supine. In the D1 group, patients were administered 20 mL of 0.25% isobaric bupivacaine with 0.5 mcg/kg of dexmedetomidine.

Intervention Type DRUG

The transverse abdominis plane (TAP) block

Patients in the D2 group received 20 mL of 0.25% isobaric bupivacaine with 1 mcg/kg of dexmedetomidine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* with ASA physical status I or II
* scheduled for elective unilateral inguinal hernioplasty under spinal anesthesia
* aged 18 to 60 years
* both genders

Exclusion Criteria

patient refusal, BMI ≥ 40 kg/m2 incapacity to engage in pain assessment contraindications to spinal anesthesia (e.g., coagulopathy, skin infection)

\- and intolerance to the research medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Adel Ali Hassan

Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Port Said University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Egyptian liver hospital

Al Mansurah, Ansoura, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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CT2023-010

Identifier Type: -

Identifier Source: org_study_id