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Impact of Segmental Spinal Anesthesia on Lung Function in Laparoscopic Gallbladder Surgery: A Pilot Study

Impact of Segmental Spinal Anesthesia on Pulmonary Function and Outcomes in Laparoscopic Cholecystectomy: A Randomized Controlled Pilot Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/092547
Enrollment
60
Registered
2025-08-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Interventions

Intervention1: Segmental Thoracic Spinal anaesthesia group: Patients will receive segmental thoracic spinal anaesthesia, in the form of medications injected into the space around their spinal cord in

Sponsors

AIIMS Rishikesh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 70 years All genders American Society of Anaesthesiology physical status I till III

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Contraindications to spinal anaesthesia (e.g., bleeding diathesis, infection) 3. Pregnancy 4.BMI more than 35 5.Severe systemic disease (ASA IV) 6.Patients having pre-existing severe respiratory illnesses (ARISCAT Score more than 44) 7. Vertebral deformity or previous spine surgeries 8. Allergy to local anaesthetics 9. Inadequate spinal anaesthesia effects 10. Intraoperative changes in surgery plan

Design outcomes

Primary

MeasureTime frame
Peak expiratory flow rate (assessed using a hand-held spirometer) Timepoint: T0- preoperative T1-6 hours post operative period T2- 24 hours post operative period T3-48 hours post operative period

Secondary

MeasureTime frame
1. Breath holding time and SpO2 2. Postoperative lung aeration score (USG assessed) 3.Trans-diaphragmatic excursion (ultrasound assessed Delta TDI) 4. Other postoperative pulmonary complications (haemodynamic, pulmonary & other system) 5. Satisfaction scores of patients & surgeons Timepoint: Predefined time points [preoperative (T0), postoperative (T1) at 6 hr, postoperative day 1 (T2) 24 hr, postoperative day 2 (T3) 48 hr for breath holiding time and spo2 and for Trans-diaphragmatic excursion (ultrasound assessed Delta TDI) Preoperative period (time point A), five minutes after induction (time point B), five minutes after pneumoperitoneum (time point C), at the end of surgery but before extubation (time point D), after one-hour post-extubation in the postoperative room (time point E), postoperative (T1) at 6 hr, postoperative day 1 (T2) 24 hr, postoperative day 2 (T3) 48 hr for Postoperative lung aeration score (USG assessed)

Countries

India

Contacts

Public ContactDr Nikita Choudhary

AIIMS Rishikesh

choudhary.20nikita@gmail.com9039134347

Outcome results

None listed

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