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

Phase 2

Recruiting

• Conditions: Laparoscopic Sleeve Gastrectomy
• Interventions: Drug: Dexmedetomidine infusion; Procedure: Paragastric neural block; Procedure: Laparoscopic Transversus Abdominis Plane (LTAP) block

• Registration Number: NCT06970626
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-03
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-05-06
• Last Update Submitted: 2025-05-06
• Study First Posted: 2025-05-14
• Last Update Posted: 2025-05-14
• Primary Completion: 2025-06-04
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Dexmedetomidine infusion	This group (Group D) will receive intravenous loading dose of dexmedetomidine at 0.5 μg/kg ideal body weight (concentration 2 μg/ml) over 15 minutes prior to anesthesia induction, followed by 10 ml of 0.9% sodium chloride over 60 seconds during anesthetic induction. Post-intubation, Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal. 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.
Group D	Paragastric neural block	This group (Group D) will receive intravenous loading dose of dexmedetomidine at 0.5 μg/kg ideal body weight (concentration 2 μg/ml) over 15 minutes prior to anesthesia induction, followed by 10 ml of 0.9% sodium chloride over 60 seconds during anesthetic induction. Post-intubation, Dexmedetomidine will be maintained at 0.5 μg/kg/h ideal body weight via a syringe pump until trocar removal. 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.
Group P	Paragastric neural block	This group (Group P) will receive Paragastric neural block (PGNB) with laparoscopic TAP block (LTAP). 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. 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.
Group P	Laparoscopic Transversus Abdominis Plane (LTAP) block	This group (Group P) will receive Paragastric neural block (PGNB) with laparoscopic TAP block (LTAP). 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. 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.

Primary Outcome Measures

Name	Time	Method
Patient satisfaction using the QoR 40 questionnaire	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)
Opioid Consumption	Opioid consumption will be measured at 4, 8, and 12 hours postoperatively	Total opioids consumed by the patient will be recorded

Secondary Outcome Measures

Name	Time	Method
Heart Rate	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.
Time to mobilize	Postoperative day 1	The time to which the patient will be able to start mobilization after surgery will be recorded (in minutes)
Incidence of nausea and vomiting	Postoperative day 1	The incidence of nausea and vomiting after surgery will be recorded
Baseline demographics	preoperatively	Age, sex, body mass index (BMI), and comorbidities will be recorded
Blood Pressure	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.

Trial Locations

Locations (1)

Alexandria Main University Hospital; 🇪🇬 Alexandria, Egypt