Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is implemented within the enhanced recovery protocol in our facility to improve participants' recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery, the investigators intended to test the efficacy of opioids free anaesthesia on the quality of recovery and postoperative narcotic use.

Official Title
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Quality of Recovery of Opioid Free Anaesthesia Versus Opioids Anaesthesia Within Enhanced Recovery Protocol Following Laparoscopic Sleeve Gastrectomy in Saudi Arabia, Randomized Controlled Trial

Conditions
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Narcotics, Recovery Quality, Analgesia, Bariatric Surgery

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Ketamine
* Drug: Dexmedetomidine Injection [Precedex]
* Procedure: Oblique subcostal transversus abdominis plane block
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 70 ASA II - III adult patients (18-60 years old) Elective laparoscopic bariatric surgery. Body mass index (BMI) is from 40 to 60 Trocar sites at or above the umbilicus (T 10 dermatome). Exclusion Criteria: Allergy to amino-amide local anaesthetics, presence of coagulopathy local skin infection at injection sites, preoperative chronic dependence upon opioid and NSAID medications, liver or renal insufficiency, history of psychiatric or neurological disease, deafness, previous open surgery, patients who need to be converted to open surgery with more tissue trauma, ASA (American society of anesthesiologists) class above III were excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Opioids anesthesia<br>received propofol-fentanyl induction of anaesthesia plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side | Drug: Fentanyl<br>* opioids anaesthesia<br>Procedure: Oblique subcostal transversus abdominis plane block<br>* Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane<br>|
| Active Comparator: OFA<br>received preinduction with dexmeditomidine 0.1µg.kg-1 over 10 min. Induction with propofol 1.5 mg.kg-1-ketamine (ketofol 3:1 mixture) induction plus maintenance mixture of dexmedetomidine 0.5µg.kg-1.h-1, ketamine 0.5mg.kg-1.h-1, and lidocaine 1 mg.kg-1.h-1 plus ultrasound-guided Bilateral oblique subcostal TAP block using 20ml of bupivacaine hydrochloride 0.25% (Marcaine, Astra Zeneca UK) in each side (total volume of 40 ml) deposited equally on each side | Drug: Ketamine<br>* ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia<br>Drug: Dexmedetomidine Injection [Precedex]<br>* alpha 2 agonist with sedative, analgesic effect<br>Procedure: Oblique subcostal transversus abdominis plane block<br>* Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane<br>Drug: Lidocaine<br>* infusion of lidocaine 2%(1mg/kg/h)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of recovery 40 questionnaire (QoR-40) | postoperative quality of recovery | At 6 hours | 
| Quality of recovery 40 questionnaire (QoR-40) | postoperative quality of recovery | At 24th h (period of time between 6 and 24 hours) as repeated measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pethidine consumption |  | 24 hours | 
| Numerical rating scale (NRS) | visual analogue scale postoperatively | 24 hours |