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NCT Number: NCT06970626

Quality of Recovery in Laparoscopic Sleeve Gastrectomy Using Dexmedetomidine Infusion Versus Laparoscopic TAP Block in Combination With Paragastric Neural Block

The goal of this clinical trial is to learn which is better, combining Dexmedetomidine infusion and paragastric neural block or combining laparoscopic TAP block and paragastric neural block to enhance recovery after laparoscopic sleeve gastrectomy.

The main questions it aims to answer are:

Will using paragastric neural block (PGNB) combined with dexmedetomidine infusion give better recovery or using PGNB combined with laparoscopic transversus abdominis plane (LTAP) block in patients undergoing laparoscopic sleeve gastrectomy.

This will be assessed by:

Recording how much opioids were consumed by the patients Hemodynamic stability of the enrolled patients Pain scores as given by the patient The quality of postoperative patient recovery How many patients encountered nausea or vomiting

Recruiting

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Key information

Conditions

Laparoscopic Sleeve Gastrectomy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Alexandria Main University Hospital

Alexandria, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status II- III
  • BMI 35- 50 kg/m2

Exclusion criteria

  • Significant hepatic, renal, neuromuscular, or cardiac impairments
  • Extreme obesity (BMI > 50 kg/m2)
  • Patients on current opioid medication
  • Allergies to dexmedetomidine or bupivacaine

Treatment and study plan

Dexmedetomidine infusion

Drug

Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal.

Paragastric neural block

Procedure

Paragastric neural block (PGNB) will be administered using a 25-gauge needle attached to a venous catheter extension, introduced through the left 12 mm port. Infiltration of 20 mL undiluted 0.5% bupivacaine will be performed at six levels in the fatty tissue of the paragastric area, including the lesser omentum, vagus nerve, esophago-gastric junction, proximal stomach, mid-stomach, distal antrum, hepatic artery, and left gastric artery, with the needle cap removed under direct vision throughout the procedure.

Laparoscopic Transversus Abdominis Plane (LTAP) block

Procedure

LTAP will be administered after insufflation before insertion of the right and left-handed ports. 30 mL of 0.25% bupivacaine will be injected into the posterolateral subcostal regions on both sides. The correct placement will be confirmed by observing the spread of fluid between the transversus abdominis and the internal oblique muscle layers laparoscopically

Primary outcomes

  1. Opioid Consumption

    Time frame: Opioid consumption will be measured at 4, 8, and 12 hours postoperatively

    Total opioids consumed by the patient will be recorded

  2. Patient satisfaction using the QoR 40 questionnaire

    Time frame: Postoperative day 1

    Patient satisfaction with the procedure done will be measured using the QoR (quality of recovery)40 questionnaire. Scores range from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery)

Secondary outcomes

  1. Heart Rate

    Time frame: Heart rate will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.

    Heart rate (beats/min) will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.

  2. Time to mobilize

    Time frame: Postoperative day 1

    The time to which the patient will be able to start mobilization after surgery will be recorded (in minutes)

  3. Incidence of nausea and vomiting

    Time frame: Postoperative day 1

    The incidence of nausea and vomiting after surgery will be recorded

  4. Baseline demographics

    Time frame: preoperatively

    Age, sex, body mass index (BMI), and comorbidities will be recorded

  5. Blood Pressure

    Time frame: Blood pressure will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.

    Blood pressure (mmHg) will be monitored continuously every 5 minutes and will be recorded prior to induction, post-induction, after the loading dose of dexmedetomidine, 4 hours and 12 hours postoperatively.

Study contacts

Contact information is provided by the study sponsor or research team.

Mai A El-Sayed, Lecturer of Anesthesia

CONTACT

[email protected]

00201287459922

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 14, 2025
Registry last updated
May 14, 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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