Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in Quadratus Lumborum Block in Patient Undergoing Caesarean Section

NCT07072650 | Completed Phase 1 DMC

• 1 other identifier: 4/2025 in 7/01/2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are:

1. 1.does adding dexmedetomidine enhance analgesia time?
2. 2.does adding dexmedetomidine reduce recovery time?
3. 3.does adding dexmedetomidine lower the need of analgesic medication after surgery? Study include 80 female pregnant non-obese patients scheduled for elective caesarean section.

Conditions

Dexmedetomidine; Quadratus Lumborum Block; Postoperative Analgesia; Caesarean Section

Keywords

dexmedetomidine; Quadratus lumborum block; caesarean section

Outcome Measures

Primary Outcomes (1)

• The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.

  The first 24 hours postoperatively

Secondary Outcomes (6)

• The time to the first analgesic request (within the first 24 hours postoperatively )

  over the first 24 hours postoperatively

• The total analgesic consumption

  Over the first 24 hours postoperatively

• Sedation levels

  At 2, 4, 6, 12, and 24 hours postoperatively

• Postoperative nausea and vomiting (PONV)

  Within the first 24 hours

• Mean Blood Pressure (MBP)

  Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes

Study Arms (2)

Group dB

ACTIVE COMPARATOR

Adding Dexmedetomidine

Drug: Dexmedetomidine

Group B

NO INTERVENTION

Only bupivacaine

Interventions

Dexmedetomidine DRUG

Studying combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS) in elective surgery in Bint Al-Huda Hospital.

Group dB

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age over 18 years' old and less 40 years.
• With body mass indices (BMI) between 18.5 and 34.9 kg/m²
• Pregnancy more than 37 weeks with single fetus.
• Intact membranes.
• Women with a singleton pregnancy.

You may not qualify if:

• ASA class III or higher,
• contraindications to spinal anesthesia,
• mental or neurological disorders,
• chronic heart, renal, or liver diseases,
• emergency surgery,
• a history of blood coagulation disorders,
• allergies or contraindications to the study drugs,

Sponsors & Collaborators

• Majid Fakhir Mutar Alhamaaidah: lead

Study Sites (1)

Bint Al-Huda Hospital/ thi qar office directorate

Nasiriyah, Thi Qar, 64001, Iraq

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Scientific committee, Dep. of Anesthesiology, Principal Investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 18, 2025
• Study Start: January 25, 2025
• Primary Completion: May 10, 2025
• Study Completion: June 25, 2025
• Last Updated: October 2, 2025

Record last verified: 2025-07

Locations

IR (1)