Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

Analgesia Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285255
• Other study ID #: OFA
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: August 1, 2020

Study information

• Verified date: March 2020
• Source: Al Mashfa Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Bariatric Surgery
• Narcotics
• Recovery Quality

Intervention

Drug:
• Fentanyl
opioids anaesthesia
• Ketamine
ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
• Dexmedetomidine Injection [Precedex]
alpha 2 agonist with sedative, analgesic effect

Procedure:
• Oblique subcostal transversus abdominis plane block
Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane

Drug:
• Lidocaine
infusion of lidocaine 2%(1mg/kg/h)

Locations

Country	Name	City	State
Saudi Arabia	Al Mashfa medical center	Khobar	Eastern Provence

Sponsors (1)

Lead Sponsor	Collaborator
Al Mashfa Medical Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of recovery 40 questionnaire (QoR-40)	postoperative quality of recovery	At 6 hours
Primary	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	Pethidine consumption		24 hours
Secondary	Numerical rating scale (NRS)	visual analogue scale postoperatively	24 hours