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

Not Applicable

Completed

• Conditions: Dexmedetomidine; Quadratus Lumborum Block; Postoperative Analgesia; Caesarean Section
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT07072650
• Lead Sponsor: Majid Fakhir Mutar Alhamaaidah

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.

Study Timeline

• Study Start: 2024-05-10
• Primary Completion: 2024-11-15
• Study Completion: 2025-02-10
• Study First Submitted: 2025-06-28
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group dB	Dexmedetomidine	Adding Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
The primary outcome measured was the pain level postoperatively. 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 Outcome Measures

Name	Time	Method
The time to the first analgesic requirement (over the first 24 hours postoperatively )	over the first 24 hours postoperatively
Sedation levels	At 2, 4, 6, 12, and 24 hours postoperatively	Sedation levels were also monitored using the Ramsay Sedation Scale which helps assess the patient's level of sedation and consciousness; was used to assess postoperative sedation 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	Measured in mmHg
The total analgesic consumption	Over the first 24 hours postoperatively
Heart Rate (HR)	Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes	Measured as beats/minute

Trial Locations

Locations (1)

Bint Al-Huda Hospital/ thi qar office directorate; 🇮🇶 Nasiriyah, Thi Qar, Iraq