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Completed

NCT Number: NCT07380503

Analgesic Efficacy of Adding Different Doses of Dexmedetomidine as Adjuvants With Bupivacaine vs.Bupivacaine Only in Ultrasound-guided Erector Spinae Plane Block in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery. A Randomized Controlled Double Blinded Study.

Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine only in ultrasound-guided erector spinae plane block in morbidly obese patients undergoing Laparoscopic Bariatric surgery. A RANDOMIZED CONTROLLED DOUBLE BLINDED STUDY.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ahmed Abdalla Mohamed

Cairo, 11451, Egypt

About this study

Bariatric surgery is recognized as an essential and effective treatment for obesity and relevant metabolic diseases, such as type 2 diabetes . With the promotion of enhanced recovery after surgery (ERAS) in bariatric surgery, the administration of the ERAS protocol has been widely accepted . Compared with traditional treatment, ERAS reduces the potential opportunity for postoperative complications, ultimately improving the quality of care for patients . Inadequate postoperative pain management for patients may increase the amount of opioid analgesic drugs consumed, prolong time to off-bed activity and hospitalization, augment the incidence of relevant complications, increase medical costs, and reduce the quality of life Laparoscopic bariatric surgeries are considered minimally invasive procedures, but they can cause severe pain . Opioids are excellent analgesics, but they have many side effects as respiratory depression, which may further complicate pain management in bariatric surgeries, particularly in cases with obstructive sleep apnea . Other comorbidities such as diabetes mellitus and cardiovascular diseases that are common in patients with obesity can also lead to difficulties with pain management . This complexity highlights the challenges of the optimal choice of analgesia in bariatric surgery.

The new regional blocking technique (Erector spinae plane block) can utilize to reduce postoperative pain effectively in various surgical procedures such as breast, thoracic, abdominal and lumbar surgery . However, although usually the use of long-acting local anesthetics (LAs), not provide long duration of action . Even though continuous catheter-based nerve block can prolong the postoperative pain relief time, this technique requires additional time and cost, and increases the risk of infection and neurological complications Dexmedetomidine (DEX) is a highly selective alpha-2 adrenergic receptor agonist with sedative and analgesic sparing effects, reduced delirium and agitation, with additive perioperative sympatholysis, cardiovascular stabilizing effects, and preservation of respiratory function..

In previous clinical studies, DEX as adjuvant to LAs as the potential to prolong blockade duration. However, it remains unclear whether Dex as an adjunct for bupivicaine to ESPB can significantly improve the quality of postoperative analgesia and recovery after Laproscopic bariatric surgery in morbidly obese patients. Thus, the main objective of the present study was to explore the effects of different dosages of Dex as an adjunct for bupivicaine combined with ESPB on the quality of postoperative analgesia and recovery and achieve opioid free anasthesia in patients following laproscopic bariatric surgery

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age starting from 21 to 60 years.
  • Genders eligible for study: Male and female sexes.
  • ASA I-III
  • Undergoing Laparoscopic bariatric surgery.
  • BMI > = 40.

Exclusion criteria

  • Patient refusal
  • Known allergy to local anesthetics and adjuvant drugs used (dexamedatomedine)
  • Bleeding disorders; platelets count <50,000, prothrombin concentration < 60% or any coagulopathy disorder.
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • ASA -IV
  • Neurological disorders
  • Patient with psychiatric disorders
  • Failed block is claimed if the patient required more than 2 doses of rescue analgesia in the first 2 hrs post operative , failed block cases will be recorded , excluded and managed according to the institutional regulations (opioid analgesia).

Treatment and study plan

Analgesic Efficacy of adding different doses of dexmedetomidine

Drug

Analgesic Efficacy of adding different doses of dexmedetomidine as adjuvants with bupivacaine vs. bupivacaine

Primary outcomes

  1. Postoperative opioid consumption in Day 1

    Time frame: Day 1

    Postoperative opioid consumption in Day 1

Secondary outcomes

  1. Visual Analogue Scale

    Time frame: Ffirst day

    Visual Analogue Scale (VAS) pain score assessed immediately postoperatively and then at 30 minutes, 1, 2, 4, 6, 12 and 24 h. Scores (1-3) were considered mild pain, (4-6) moderate pain and (7-10) severe pain

  2. Time to first postoperative rescue analgesia

    Time frame: Time to first postoperative rescue analgesia in one day

    Total dose of fentanyl required intraoperative (including induction dose) to be 200 microgram

  3. Ramzy sedation score:

    Time frame: Day 1

    • Score 1:Awake;agitated or restless or both.
    • Score 2: Awake; cooperative, oriented and tranquil.
    • Score 3: Awake but responds to commands only
    • Sore 4: Asleep; brisk response to light glabellar tap or loud auditory stimulus.
    • Score 5: Asleep; sluggish response to light glabellar tap or loud auditory stimulus
    • Score 6: Asleep; no response to glabellar tap or loud auditory stimulus
  4. Effect on arterial blood pressure

    Time frame: Day 1

    Effect on arterial blood pressure

  5. Number and percentage of people developing side effects of block (pneumothorax, vascular injury).

    Time frame: Day 1

    Number and percentage of people developing side effects of block (pneumothorax, vascular injury).

  6. Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.

    Time frame: Through Study Completion

    Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.

  7. Local anesthetic toxicity.

    Time frame: Through Study Completion

    Local anesthetic toxicity

  8. Post operative nausea and vomiting.

    Time frame: Through Study Completion

    Post operative nausea and vomiting.

  9. Effect on heart rate

    Time frame: Day 1

    Effect on heart rate

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Ahmed Abdalla Mohamed Ali Nasr
  • Aya Sayed Ali Ahmed Mostafa
  • Dina Soliman Mohammed Idris
  • Mohamed Ahmed Abd El Hamed Shamma
  • Mohamed Nabil Elshafie Abdulkader

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Mar 9, 2026

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.