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

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age20-60
SponsorAlexandria University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) physical status II- III

BMI 35- 50 kg/m2

Disqualifiers

Significant hepatic, renal, neuromuscular, or cardiac impairments

Extreme obesity (BMI > 50 kg/m2)

Patients on current opioid medication

Allergies to dexmedetomidine or bupivacaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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/Surgery

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group DActive comparator 2 interventions
Group B: Group PActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Opioid Consumption

Total opioids consumed by the patient will be recorded

Time frame
Opioid consumption will be measured at 4, 8, and 12 hours postoperatively
2

Patient satisfaction using the QoR 40 questionnaire

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)

Time frame
Postoperative day 1

Secondary outcomes

1

Heart Rate

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 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.
2

Time to mobilize

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

Time frame
Postoperative day 1
3

Incidence of nausea and vomiting

The incidence of nausea and vomiting after surgery will be recorded

Time frame
Postoperative day 1
4

Baseline demographics

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

Time frame
preoperatively

Other outcomes

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