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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04285255
Other study ID # OFA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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