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

Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in QL3 in Patient Undergoing Caesarean Section

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07072650
Enrollment
80
Registered
2025-07-18
Start date
2025-01-25
Completion date
2025-06-25
Last updated
2025-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean Section, Dexmedetomidine, Postoperative Analgesia, Quadratus Lumborum Block

Keywords

dexmedetomidine, Quadratus lumborum block, caesarean section

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.

Interventions

DRUGDexmedetomidine

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.

Sponsors

Majid Fakhir Mutar Alhamaaidah
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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,

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frameDescription
The total analgesic consumptionOver the first 24 hours postoperatively
Sedation levelsAt 2, 4, 6, 12, and 24 hours postoperativelySedation 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
The time to the first analgesic request (within the first 24 hours postoperatively )over the first 24 hours postoperatively
Mean Blood Pressure (MBP)Perioperative period at intervals of 0, 5, 10, 20, and 30 minutesMeasured in mmHg
Heart Rate (HR)Perioperative period at intervals of 0, 5, 10, 20, and 30 minutesMeasured as beats/minute
Postoperative nausea and vomiting (PONV)Within the first 24 hours

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026