Development of a novel opioid-free anesthesia protocol for laparoscopic surgery

Opioid-free anesthesia with magnesium sulphate (OFAM) and regional parietal blocks (RPB) vs opioids inclusive anesthesia (OIA) in laparoscopic surgery. Postoperative pain control and adverse events during the first 24 hours after surgery.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15228105

Enrollment

220

Registered

2023-12-02

Start date

2020-10-01

Completion date

Unknown

Last updated

2025-05-05

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

Conditions

Intraoperative and postoperative pain control in laparoscopic abdominal surgery Surgery

Interventions

Intervention groups Preoperative management: Based on ideal body weight (IBW), patients will be premedicated with 6 ml/kg crystalloids in 30 minutes, i.m. 75 mcg clonidine, and i.v. 0.05 mg/kg midazol

finally, single-shot USG-bilateral RSB with the administration of 10 ml of ropivacaine (0.3%), for each side, in an overall volume of 20 ml, according to patient BMI. The efficacy and extension of the

after that, an intravenous infusion of 8 mg/kg/h magnesium sulfate 5% will be started. Intraoperative management: A continuous intravenous infusion of 90 mg ketorolac (2 ml/h) in a solution of 48 ml

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive patients older than 18 years old who planned for laparoscopic scheduled abdominal surgery and will undergo general anesthesia

Exclusion criteria

Exclusion criteria: 1. Age below 18 years old 2. Pregnant women 3. Confirmed diagnosis of hypermagnesemia, hyponatremia, hypocalcemia, hyperkalemia 4. Acidosis states 5. Acute or chronic kidney disease 6. Hypothyroidism 7. Hypoadrenocorticism 8. Neuromuscular disorders 9. Bradycardia 10. Bradyarrhythmia 11. Atrioventricular block 12. Pacemaker 13. Heart failure associated with hypotension and reduced cardiac function 14. Shock

Design outcomes

Primary

Measure	Time frame
Pain measured using a Numerical Rating Scale (NRS) in the postoperative period at the end of surgery (T0) and at 6 (T1)-12 (T2)-18 (T3)-24 (T4) hours	—

Secondary

Measure	Time frame
Composite of postoperative adverse events such as hypoxemia, defined as a SpO2 level of less than 95% with a need for oxygen supplementation; postoperative ileus, defined as an absence of flatus or stools; postoperative nausea and vomiting with the need for rescue antiemetic medication, unplanned intensive care unit (ICU) admission, mobilization recovery time and in-hospital length of stay measured using patient study records within the first 24 hours after extubation	—

Measure

Time frame

Composite of postoperative adverse events such as hypoxemia, defined as a SpO2 level of less than 95% with a need for oxygen supplementation; postoperative ileus, defined as an absence of flatus or stools; postoperative nausea and vomiting with the need for rescue antiemetic medication, unplanned intensive care unit (ICU) admission, mobilization recovery time and in-hospital length of stay measured using patient study records within the first 24 hours after extubation

—

Countries

Italy

Contacts

Public ContactGiuseppe Accurso

giuseppe.accurso@policlinico.pa.it+39 0916552703

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026