Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty

NCT07194694 | Completed Phase 3 DMC

• 1 other identifier: MD 42
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare the effect of adding dexmedetomidine versus ketamine to bupivacaine in transversus abdominis plane block in patients undergoing unilateral inguinal hernioplasty. The key questions it is expected to answer are: To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block? To investigate the pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation. researchers will rely on three groups: Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline. Group B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline. Group C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline. Participants will: have general anesthesia in their planned unilateral hernioplasty. have an ipsilateral US guided TAP block (posterior approach) using one of the three study solutions at the end of the surgery prior to be waked up. Measure their Numeric Pain Rating Scale (NRS) at rest and coughing at particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.

Conditions

Postoperative Pain Relief

Outcome Measures

Primary Outcomes (1)

• Change in Numeric Pain Rating Scale

  The Numeric Pain Rating Scale (NRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where: 0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity or average pain level.

  Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively

Secondary Outcomes (1)

• Change in Mean arterial blood pressure

  Immediately postoperative - 2 hours postoperative - 4 hours postoperative

Study Arms (3)

DEX on TAP

ACTIVE COMPARATOR

Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.

Drug: Dexmedetomidine & Bupivacaine.

KET on TAP

ACTIVE COMPARATOR

Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.

Drug: ketamine and bupivacaine injection

TAP

PLACEBO COMPARATOR

Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.

TAP

Dexmedetomidine & Bupivacaine. DRUG

Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.

DEX on TAP

ketamine and bupivacaine injection DRUG

Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.

KET on TAP

Eligibility Criteria

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

You may qualify if:

• Patients undergoing unilateral inguinal hernioplasty of ASA I or II.
• Age group: 18-60 years old.

You may not qualify if:

• Patient refusal.
• known allergy to any of the used drugs
• ASA III or above
• Coagulation disorders and thrombocytopenia
• Body mass index (BMI) \>30
• Infection at needle insertion site
• Patients undergoing bilateral inguinal hernioplasty

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine; Bupivacaine; Ketamine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Sampling Method: Simple random sample. Randomization: Computer generated random list. Blinding: The patient, the physician performing the block and the investigator will be blinded as regard tools and patient's group. Concealment: Randomization list will be concealed from all members off the study, known only by one person which is not included in it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer at Department: Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.

Model Details: At the end of surgery an ipsilateral US guided TAP block (posterior approach) will be given to all the patients by placing linear US probe (high frequency probe 10-12 MHz) connected to a portable US unit initially in the mid-axillary plane midway between the lower costal margin and the highest point of iliac crest, then it will be moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site is superficial to the aponeurosis near quadratus lumborum. while the patient in supine position with slight lateralization After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in place and after negative suction 5 ml saline 0.9% will be injected to verify the right place, then one of the three study solutions will be injected.

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: October 22, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 20, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)