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NCT Number: NCT07072650

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Bint Al-Huda Hospital/ thi qar office directorate

Nasiriyah, Thi Qar, 64001, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

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.

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.

    Time frame: The first 24 hours postoperatively

Secondary outcomes

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

    Time frame: over the first 24 hours postoperatively

  2. The total analgesic consumption

    Time frame: Over the first 24 hours postoperatively

  3. Sedation levels

    Time frame: 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

  4. Postoperative nausea and vomiting (PONV)

    Time frame: Within the first 24 hours

  5. Mean Blood Pressure (MBP)

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

    Measured in mmHg

  6. Heart Rate (HR)

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

    Measured as beats/minute

Sponsors and collaborators

Lead sponsor

Majid Fakhir Mutar Alhamaaidah

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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