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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07380503
Enrollment
78
Registered
2026-02-02
Start date
2025-01-01
Completion date
2025-10-15
Last updated
2026-03-09

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

Conditions

ESPB With Dexmetomidine May Provide Analgesia

Brief summary

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.

Detailed description

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

Interventions

DRUGAnalgesic Efficacy of adding different doses of dexmedetomidine

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

Sponsors

Cairo University
Lead SponsorOTHER
Ahmed Abdalla Mohamed Ali Nasr
CollaboratorUNKNOWN
Dina Soliman Mohammed Idris
CollaboratorUNKNOWN
Mohamed Nabil Elshafie Abdulkader
CollaboratorUNKNOWN
Mohamed Ahmed Abd El Hamed Shamma
CollaboratorUNKNOWN
Aya Sayed Ali Ahmed Mostafa
CollaboratorUNKNOWN

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid consumption in Day 1Day 1Postoperative opioid consumption in Day 1

Secondary

MeasureTime frameDescription
Visual Analogue ScaleFfirst dayVisual 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
Time to first postoperative rescue analgesiaTime to first postoperative rescue analgesia in one dayTotal dose of fentanyl required intraoperative (including induction dose) to be 200 microgram
Ramzy sedation score: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
Effect on arterial blood pressureDay 1Effect on arterial blood pressure
Number and percentage of people developing side effects of block (pneumothorax, vascular injury).Day 1Number and percentage of people developing side effects of block (pneumothorax, vascular injury).
Number and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.Through Study CompletionNumber and percentage of side effects related to adjuvant drugs as bradycardia and hypotension.
Local anesthetic toxicity.Through Study CompletionLocal anesthetic toxicity
Post operative nausea and vomiting.Through Study CompletionPost operative nausea and vomiting.
Effect on heart rateDay 1Effect on heart rate

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026