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A study to compare two different techniques to reduce postoperative pain in gynaecological laparoscopy surgery

Comparison of intraperitoneal irrigation with sodium bicarbonate solution versus normal saline in operative gynaecological laparoscopy to reduce postoperative pain: a randomized control trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096106
Enrollment
60
Registered
2025-10-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: N839- Noninflammatory disorder of ovary,fallopian tube and broad ligament, unspecified

Interventions

Intervention1: Intraperitoneal irrigation with sodium bicarbonate solution: Intraperitoneal wash with 50 ml of 7.5% sodium bicarbonate solution diluted in 1000 ml of normal saline for 5 minutes follow

Sponsors

University College of Medical Sciences and Guru Teg Bahadur Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Women aged 18-65 years - American society of anesthesiologist physical status classification 1 or 2 - Those undergoing elective operative laproscopic surgery for benign gynaecological conditions.

Exclusion criteria

Exclusion criteria: - History of chronic pain, psychiatric illness, opioid use, alcohol - Metabolic/ respiratory alkalosis - Electrolyte imbalances - Chronic kidney disease, liver disease, cardiovascular or respiratory diseases - Malignancy - Conversion to laparotomy - Diagnostic laproscopy - Pregnancy - Infection in post operative period - Known allergy to study solutions

Design outcomes

Primary

MeasureTime frame
Post operative pain measured by visual analogue scale (VAS) (0-10) at Right and left shoulder tip, port sites, abdomen excluding port sites and back recorded as Mean±SD in both the groups.Timepoint: Post operative pain measured by visual analogue scale (VAS) (0-10) at 6, 12, 24, 48 hours and 1 week post procedure

Secondary

MeasureTime frame
- Total analgesic requirement in both the groups (Type, dose, and time to first request) - Incidence of PONV in both the groups. (Use of antiemetics) - Comparison of inflammatory markers (CBC, CRP, DLC, NLR, PLR, MLR) post laparoscopy in both the groups. - Mean time for first oral intake, ambulation and duration of hospital stay from end of surgery in both the groups.Timepoint: Postoperative day 1 and day 3 (inflammatory markers)

Countries

India

Contacts

Public ContactDr Priya Vinod Kumar Singh

University College of Medical Sciences and GTB Hospital

rashmi.malik2011@gmail.com9810645212

Outcome results

None listed

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