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Post laparoscopy pain reduction project

POst LaparoscopY Pain REduction Project (POLYPREP III): intraperitoneal normal saline (INSI) infusion versus intraperitoneal Ringer's lactate (INRL) infusion: a Randomised Control Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17589993
Enrollment
80
Registered
2020-12-26
Start date
2020-02-01
Completion date
Unknown
Last updated
2021-01-05

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

Conditions

Post laparoscopy pain following benign gynaecological surgery, post-surgical pain Surgery

Interventions

All women who are scheduled for elective laparoscopic surgery with benign gynaecological indication will be assessed for eligibility one day before the operation date on the gynaecology ward or at the
each of these envelopes contained a colour-coded paper with the legend ‘INSI’ (for intraperitoneal normal saline, group A) or ‘INRL’ (for intraperitoneal Ringer's lactate, group B). The next availabl

Sponsors

University of Malaya
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 18 years and above 2. Scheduled for laparoscopic surgery with a benign gynaecological indication like laparoscopic cystectomy and laparoscopic salpingectomy/salpingoophorectomy at University Malaya Medical Centre 3. American Society of Anaesthesiologists (ASA) classification I-II: 3.1. ASA I is a normal healthy patient, non-smoking, no or minimal alcohol use 3.2. ASA II is a patient with mild systemic disease without substantive functional limitations (such as BMI <40 kg/m², mild lung disease, well-controlled diabetes mellitus or hypertension, current smoker, social alcohol drinker, or pregnancy)

Exclusion criteria

Exclusion criteria: 1. Conversion to laparotomy 2. Allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), paracetamol, or tramadol 3. Pregnancy 4. Unable to read and sign information sheet and consent form 5. Pre-existing shoulder pain which is based on doctor and clinical report before the study 6. Intellectual disability based on doctor and clinical report 7. Allergy to Ringer’s lactate solution

Design outcomes

Primary

MeasureTime frame
1. Intensity and incidence of post laparoscopic pain in the shoulder, upper abdomen, and lower abdominal area measured using a participant questionnaire with a 0-10 numerical rating scale (NRS) at 1, 2, and 3 days

Secondary

MeasureTime frame
1. Post-operative use of analgesia collected using a participant questionnaire at 1, 2, and 3 days 2. Nausea, vomiting, and abdominal distension measured using a participant questionnaire at 1, 2, and 3 days 3. Time to pass first flatus after surgery collected using a participant questionnaire at 1, 2, and 3 days 4. Duration of hospital stay collected from patient notes at the time of discharge

Countries

Malaysia

Contacts

Public ContactShu Jun Teing
junnieshujun2@gmail.com+60 125297948

Outcome results

None listed

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