Comparing recovery quality after laparoscopic gallbladder surgery with opioid-free versus opioid-based anesthesia
Quality of Recovery After Laparoscopic Cholecystectomy: A Prospective, Randomised, Controlled Trial Comparing Opioid Free Multimodal Analgesia Versus Opioid Based Anesthesia
This study is testing whether patients recovering from gallbladder surgery feel better with an opioid-free anesthesia compared to traditional opioid-based anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06343753 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the quality of recovery in patients undergoing elective laparoscopic cholecystectomy by comparing two anesthesia approaches: opioid-free analgesia and traditional opioid-based anesthesia. Participants will be randomly assigned to one of the two groups, with recovery assessed using the quality of recovery 15-item scale (QoR-15). The study will take place in the operating theatres of Ain Shams University Hospitals over a one-year period, ensuring a controlled and systematic approach to data collection. Both groups will receive additional analgesia through port site infiltration with bupivacaine.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with ASA classification I-II scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients who may not benefit include those with ASA classification greater than II, pregnant or breastfeeding women, and individuals with a history of chronic pain or psychiatric diseases.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery experiences and reduced opioid use for patients undergoing laparoscopic cholecystectomy.
How similar studies have performed: Other studies have shown promising results with opioid-sparing techniques in various surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria : * Age group: 18-65 year of both sex. * Patients with ASA (American society of anesthesiologist) classification I-II. * Undergoing a scheduled laparoscopic cholecystectomy Exclusion Criteria: * Pregnant or breast-feeding women * ASA physical status class \> 2 * The need to change laparoscopic surgery to an open one * Allergy to any of the drugs used in the study * local skin infection at the trocar injection site * 1st or 2nd degree Heart block * Chronic treatment by beta-blockers * HR \<50 bpm * Epilepsy or seizures * Alcohol or drug abuse * Psychiatric disease * History of chronic pain
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed El-ghanam
- Email: ahmedelghanam4411@gmail.com
- Phone: 201116171706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.