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

M

Majid Fakhir Mutar Alhamaaidah

Status and phase

Completed
Phase 1

Conditions

Postoperative Analgesia
Caesarean Section
Quadratus Lumborum Block
Dexmedetomidine

Treatments

Drug: Dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT07072650
4/2025 in 7/01/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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,

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Group dB
Active Comparator group
Description:
Adding Dexmedetomidine
Treatment:
Drug: Dexmedetomidine
Group B
No Intervention group
Description:
Only bupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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