Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Recovery Quality; Narcotics; Analgesia; Bariatric Surgery
• Interventions: Drug: Ketamine; Drug: Fentanyl; Drug: Dexmedetomidine Injection [Precedex]; Procedure: Oblique subcostal transversus abdominis plane block; Drug: Lidocaine

• Registration Number: NCT04285255
• Lead Sponsor: Al Mashfa Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-22
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-26
• Status Verified: 2020-03
• Study Start: 2020-03-01
• Primary Completion: 2020-08-01
• Study Completion: 2020-08-01
• Last Update Submitted: 2021-10-30
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OFA	Dexmedetomidine Injection [Precedex]	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
Opioids anesthesia	Oblique subcostal transversus abdominis plane block	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
OFA	Oblique subcostal transversus abdominis plane block	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
OFA	Ketamine	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
Opioids anesthesia	Fentanyl	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
OFA	Lidocaine	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

Primary Outcome Measures

Name	Time	Method
Quality of recovery 40 questionnaire (QoR-40)	At 24th h (period of time between 6 and 24 hours) as repeated measurement	postoperative quality of recovery

Secondary Outcome Measures

Name	Time	Method
Numerical rating scale (NRS)	24 hours	visual analogue scale postoperatively
Pethidine consumption	24 hours

Trial Locations

Locations (1)

Al Mashfa medical center; 🇸🇦 Khobar, Eastern Provence, Saudi Arabia