Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

October 30, 2021 updated by: Al Mashfa Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
    • Eastern Provence
      • Khobar, Eastern Provence, Saudi Arabia, 34225/7564
        • Al Mashfa medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Opioids anesthesia
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
opioids anaesthesia
Procedure: Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
Active Comparator: OFA
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
Procedure: Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
Drug: Ketamine
ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
Drug: Dexmedetomidine Injection [Precedex]
alpha 2 agonist with sedative, analgesic effect
Drug: Lidocaine
infusion of lidocaine 2%(1mg/kg/h)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery 40 questionnaire (QoR-40)
Time Frame: At 6 hours
postoperative quality of recovery
At 6 hours
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
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
Time Frame: 24 hours
24 hours
Numerical rating scale (NRS)
Time Frame: 24 hours
visual analogue scale postoperatively
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al Mashfa Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

February 22, 2020

First Submitted That Met QC Criteria

February 24, 2020

First Posted (Actual)

February 26, 2020

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 30, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OFA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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