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

NCT ID: NCT07072650

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2025-06-25

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. does adding dexmedetomidine enhance analgesia time?

2. does adding dexmedetomidine reduce recovery time?

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.

Detailed Description

Effective postoperative analgesia facilitates a mother's quick recovery, enhances early ambulation, promotes breastfeeding, and reduces the risk of postoperative thromboembolism. The aim of this study was to evaluate the postoperative analgesic efficacy of combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS). A prospective, randomized, blind, controlled trial included 80 female patients aged 18 - 40 years old who underwent cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups. Group dB received a quadratus lumborum block (QLB) with 20 ml of 0.25% bupivacaine and dexmedetomidine (0.5 μg/kg) on each side, while Group B received QLB with 20 ml of 0.25% bupivacaine alone on each side. The primary outcome measured was total analgesic consumption over 24 hours postoperatively. Secondary outcomes included Visual Analog Scale (VAS) scores, time to first analgesic request, and the incidence of side effects such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression.

Conditions

Dexmedetomidine; Quadratus Lumborum Block; Postoperative Analgesia; Caesarean Section

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group dB

Adding Dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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 B

Only bupivacaine

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Dexmedetomidine

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Majid Fakhir Mutar Alhamaaidah

OTHER

Sponsor Role: lead

Responsible Party

Majid Fakhir Mutar Alhamaaidah

Head of Scientific committee, Dep. of Anesthesiology, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bint Al-Huda Hospital/ thi qar office directorate

Nasiriyah, Thi Qar, Iraq

Countries

Iraq

Other Identifiers

4/2025 in 7/01/2025

Identifier Type: -

Identifier Source: org_study_id