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A prospective randomized control trial to assess the outcomes of Low-pressure vs standard pressure pneumoperitoneum on post-operative pain and nausea/vomiting in the first 24 hours postoperatively on patients undergoing laparoscopic cholecystectomy in a tertiary care hospital.

A prospective randomized control trial to assess the outcomes of Low-pressure vs standard pressure pneumoperitoneum on post-operative pain and nausea/vomiting on patients undergoing laparoscopic cholecystectomy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/075698
Enrollment
78
Registered
2024-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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: low pressure pneumoperitoneum- 8-10 mmHg: Patients will be allocated by randomisation into the low pressure 8-10 mmHg group and then post operative pain and nausea and vomiting will be

Sponsors

Nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients above 18 years of age patients undergoing laparoscopic cholecystectomy at Sundaram Medical Foundation

Exclusion criteria

Exclusion criteria: Patients undergoing Open Cholecystectomy Patients not willing to participate in the study Patients below the age of 18 years

Design outcomes

Primary

MeasureTime frame
To compare postoperative pain in both groups using NRS ( Numerical Rating Scale) and the number of analgesic doses over the prescribed 8hrly dose. To compare postoperative nausea/vomiting using the RINVR ( Rhodes Index of Nausea, Vomiting and Retching) as well as the number of doses of antiemetics needed post-operatively. Timepoint: The number of doses of additional analgesics and antiemetics required by each patient will be monitored. Each patient’s pain will be assessed at 1st, 2nd , 6th, 12th and 24th hour post operatively using the NRS . Each patient’s nausea and vomiting will be assessed by the RINVR at 24 hours post surgery—

Secondary

MeasureTime frame
To assess the duration postoperatively after which the patients return to oral feeding To compare intraoperative hemodynamics. To compare the mean duration of hospital stay To compare the surgeon’s ease of operation, visibility and duration of surgery. Timepoint: Intraoperatively and Postoperatively—

Countries

India

Contacts

Public ContactDr Girija

Sundaram Medical Foundation (Dr Rangarajan Memorial Hospital)

vrajakumar20@gmail.com9840182920

Outcome results

None listed

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