Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

NCT04285255 | Completed

• 1 other identifier: OFA
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Narcotics; Recovery Quality; Analgesia; Bariatric Surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pethidine consumption

  24 hours

• Numerical rating scale (NRS)

  24 hours

Study Arms (2)

Opioids anesthesia

ACTIVE COMPARATOR

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; Procedure: Oblique subcostal transversus abdominis plane block

OFA

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine Injection [Precedex]; Procedure: Oblique subcostal transversus abdominis plane block; Drug: Lidocaine

Interventions

Fentanyl DRUG

opioids anaesthesia

Opioids anesthesia

Ketamine DRUG

ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia

OFA

Dexmedetomidine Injection [Precedex] DRUG

alpha 2 agonist with sedative, analgesic effect

OFA

Oblique subcostal transversus abdominis plane block PROCEDURE

Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane

OFA; Opioids anesthesia

Lidocaine DRUG

infusion of lidocaine 2%(1mg/kg/h)

OFA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al Mashfa Medical Center: lead

Study Sites (1)

Al Mashfa medical center

Khobar, Eastern Provence, 34225/7564, Saudi Arabia

Location

Related Publications (1)

• Ibrahim M, Elnabtity AM, Hegab A, Alnujaidi OA, El Sanea O. Combined opioid free and loco-regional anaesthesia enhances the quality of recovery in sleeve gastrectomy done under ERAS protocol: a randomized controlled trial. BMC Anesthesiol. 2022 Jan 21;22(1):29. doi: 10.1186/s12871-021-01561-w.

  PMID: 35062872 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Fentanyl; Ketamine; Dexmedetomidine; Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: only the anaesthetist is one aware of the study groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2020
• First Posted: February 26, 2020
• Study Start: March 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: November 8, 2021

Record last verified: 2020-03

Locations

SA (1)