Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy

• Sponsor: Al Mashfa Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT04285255
• Collaborator: (none)
• Enrollment: 103
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 20.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Narcotics; Recovery Quality; Analgesia; Bariatric Surgery	Drug: Fentanyl; Drug: Ketamine; Drug: Dexmedetomidine Injection [Precedex]; Procedure: Oblique subcostal transversus abdominis plane block; Drug: Lidocaine	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 103 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Masking Description: only the anaesthetist is one aware of the study groups
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Mar 1, 2020
• Actual Primary Completion Date: Aug 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Arms and Interventions

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	Drug: Ketamine; ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia; Drug: 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)

Outcome Measures

Primary Outcome Measures

1. Quality of recovery 40 questionnaire (QoR-40) [At 6 hours]

   postoperative quality of recovery

2. Quality of recovery 40 questionnaire (QoR-40) [At 24th h (period of time between 6 and 24 hours) as repeated measurement]

   postoperative quality of recovery

Secondary Outcome Measures

1. Pethidine consumption [24 hours]

2. Numerical rating scale (NRS) [24 hours]

   visual analogue scale postoperatively

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Al Mashfa medical center	Khobar	Eastern Provence	Saudi Arabia	34225/7564

Sponsors and Collaborators

• Al Mashfa Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Al Mashfa Medical Center
• ClinicalTrials.gov Identifier: NCT04285255
• Other Study ID Numbers: OFA
• First Posted: Feb 26, 2020
• Last Update Posted: Nov 8, 2021
• Last Verified: Mar 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lidocaine; Fentanyl; Dexmedetomidine; Ketamine

Study Results

No Results Posted as of Nov 8, 2021