Comparison between opioid-free anaesthesia and opioid-based anaesthesia for laparoscopic tubal ligation

Comparison between opioid-free anaesthesia and opioid-based anaesthesia for laparoscopic tubal ligation- A non-inferiority randomized double-blind controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/068114

Enrollment

Registered

2024-05-30

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system Health Condition 3: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium

Interventions

Intervention1: Group OF Opioid Free: Patients in this group will receive inj. Magnesium sulphate 40mg/kg in 100 ml of saline over 15 minutes (without exceeding 2.5gm) before induction of anaesthesia.

Eligibility

Inclusion criteria

Inclusion criteria: Consenting ASA Physical Status I – II female patients undergoing laparoscopic tubal ligation under general anaesthesia.

Exclusion criteria

Exclusion criteria: BMI more than 35 Known case of allergy to opioids or to adjuvant drugs Patients with a history of postoperative nausea or vomiting Patients with history of chronic pain of any aetiology or patients who are already on opioids Patients having cognitive dysfunction with inability to comprehend questionnaires.

Design outcomes

Primary

Measure	Time frame
AUC- NRS Pain score in 24 hoursTimepoint: from the time of shifting the patient from Operation theatre to post-operative area till the completion of 24 hr	—

Secondary

Measure	Time frame
1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) 2 Rescue analgesic consumption in the first 24 h 3 PONV score 4 Rescue antiemetic consumption in the first 24 h 5 Time to Aldrete score more than or equal to 9 6 Quality of Recovery (QoR-15) score Timepoint: 1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) at the end of 3rd 6th 12th & 24th hr 2 Rescue analgesic consumption in the first 24 h 3 PONV score at at the end of 3rd 6th 12th & 24th hr 4 Rescue antiemetic consumption in the first 24hr 5 Time to Aldrete score more than or equal to 9 measure from the time of shifting the patient to post operative area 6 Quality of Recovery (QoR-15) score at the end of 24 hrs	—

Measure

Time frame

1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) 2 Rescue analgesic consumption in the first 24 h 3 PONV score 4 Rescue antiemetic consumption in the first 24 h 5 Time to Aldrete score more than or equal to 9 6 Quality of Recovery (QoR-15) score Timepoint: 1 Pain intensity using NRS Pain at Rest (NRS-R) & Movement (NRS-M) at the end of 3rd 6th 12th & 24th hr 2 Rescue analgesic consumption in the first 24 h 3 PONV score at at the end of 3rd 6th 12th & 24th hr 4 Rescue antiemetic consumption in the first 24hr 5 Time to Aldrete score more than or equal to 9 measure from the time of shifting the patient to post operative area 6 Quality of Recovery (QoR-15) score at the end of 24 hrs

—

Countries

India

Contacts

Public ContactDr Geetanjali T Chilkoti

University college of medical science and GTB hospital

sinha6659@gmail.com7827067774

Outcome results

None listed

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