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OpenTrials
Completed

NCT Number: NCT04285255

Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Narcotics Agnosia Analgesia Bariatric Surgery Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Recovery Quality Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al Mashfa medical center

Khobar, Eastern Provence, 34225/7564, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fentanyl

Drug

opioids anaesthesia

ketamine

Drug

ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia

Dexmedetomidine Injection [Precedex]

Drug

alpha 2 agonist with sedative, analgesic effect

Oblique subcostal transversus abdominis plane block

Procedure

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

Lidocaine

Drug

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

Primary outcomes

  1. Quality of recovery 40 questionnaire (QoR-40)

    Time frame: At 6 hours

    postoperative quality of recovery

  2. Quality of recovery 40 questionnaire (QoR-40)

    Time frame: At 24th h (period of time between 6 and 24 hours) as repeated measurement

    postoperative quality of recovery

Secondary outcomes

  1. Pethidine consumption

    Time frame: 24 hours

  2. Numerical rating scale (NRS)

    Time frame: 24 hours

    visual analogue scale postoperatively

Sponsors and collaborators

Lead sponsor

Al Mashfa Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2020
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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