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NCT Number: NCT06825286

Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.

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Key information

Conditions

Dexmedetomidine Bupivacaine Laparoscopic Cholecystectomy Postoperative Analgesia Quadratus Lumborum Block Ultrasound-Guided

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, ElGharbia, 31527, Egypt

About this study

When compared to conventional surgery, laparoscopic cholecystectomy is less invasive and leads to less postoperative pain. However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry' wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage.

Quadratus lamborum block (QLB) is abdominal truncal block that provides both somatic and visceral analgesia for both upper and lower abdominal surgical procedures, It was first introduced by Blanco.Currently There are 4 approaches described for QLB: lateral, posterior, anterior and intramuscular. Transmuscular (anterior) QLB Type 3 block involves injection in the plane between the psoas major (PM) and the QL muscles studies have reported spread of the injectate to the thoracic paravertebral space, as well as the spinal nerve which runs anterior to the QL muscle

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 21-65 years.
  • Both genders.
  • American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy

Exclusion criteria

  • Patient refusal
  • History of allergy to local anesthetic.
  • Liver or renal pathology affecting drug elimination
  • Menta!dysfunction or cognitive disorders.
  • Patients on chronic pain medications.
  • Body Mass Index > 40 kg/m2.
  • Coagulopathy

Treatment and study plan

Bupivacaine

Drug

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block wilh (20 ml bupivacaine 0.25%).

Bupivacaine and Dexmedetomidinc) group

Drug

Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine Imic/kg)

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia

Secondary outcomes

  1. Mean arterial blood pressure

    Time frame: At the end of the operation(Up to 48 min).

    Mean arterial blood pressure was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.

  2. Heart rate

    Time frame: At the end of the operation (Up to 48 min).

    Heart rate was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.

  3. lntraoperative fentanyl consumption

    Time frame: lntraoperatively

    Additional fentanyl dosages of 0.5 µg/kg IV was administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).

  4. Degree of pain score

    Time frame: 24 hours postoperatively

    Postoperative pain was assessed by the numerical rating scale (NRS; 0 no pain while 10 is the maximum pain) immediately after discharge to the PACU and ward at 6, 12, 18, 24 hours.

  5. Time to the first request for the rescue analgesia

    Time frame: 24 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).IV morphine 2mg was given when NRS equal or above 4.

  6. Incidence of Complication

    Time frame: 24 hours postoperatively

    Complication such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

The Effect of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2025
Registry last updated
Feb 13, 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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