Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04285255

Enrollment

103

Registered

2020-02-26

Start date

2020-03-01

Completion date

2020-08-01

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcotics, Recovery Quality, Analgesia, Bariatric Surgery

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.

Interventions

DRUGFentanyl

opioids anaesthesia

DRUGKetamine

ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia

DRUGDexmedetomidine Injection [Precedex]

alpha 2 agonist with sedative, analgesic effect

PROCEDUREOblique subcostal transversus abdominis plane block

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

DRUGLidocaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

only the anaesthetist is one aware of the study groups

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Quality of recovery 40 questionnaire (QoR-40)	At 6 hours	postoperative quality of recovery

Secondary

Measure	Time frame	Description
Pethidine consumption	24 hours	—
Numerical rating scale (NRS)	24 hours	visual analogue scale postoperatively

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026