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

NCT06703229 | Completed

• 1 other identifier: CT2023-010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Anaesthesia; Herniorrhaphy; Transversus Abdominis Plane Block

Outcome Measures

Primary Outcomes (1)

• the initial request for analgesia post-surgery

  The postoperative Visual Analogue Scale (VAS) is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" on the other end.

  24 hours

Study Arms (2)

group, D1

ACTIVE COMPARATOR

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

Drug: The Transversus Abdominis Plane (TAP) block

group, D2

ACTIVE COMPARATOR

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

Drug: The transverse abdominis plane (TAP) block

Interventions

The Transversus Abdominis Plane (TAP) block 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, D1

The transverse abdominis plane (TAP) block DRUG

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

group, D2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Egyptian liver hospital

Al Mansurah, Ansoura, 42526, Egypt

Location

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine, Port Said University

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 25, 2024
• Study Start: January 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)