Condition category
Surgery
Date applied
24/06/2019
Date assigned
26/06/2019
Last edited
25/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pain after laparoscopic surgery or ‘key-hole’ surgery is common. Although it is less severe than conventional ‘open’ surgery, patients do experience pain over the shoulder and upper abdominal region (which is not related to the skin incision site) particularly after 24 hours of surgery. Painkillers do not seem to be effective in eliminating this pain.
Intraperitoneal normal saline infusion (infusing salt water in the abdomen) has been shown to be effective in reducing pain after laparoscopic surgery; however there is only one study done previously. The purpose of this study is to evaluate the effectiveness of the proposed treatment (intraperitoneal normal saline infusion) in reducing pain after laparoscopic surgery.

Who can participate?
Women aged 18 years and above scheduled for laparoscopic surgery for a benign gynaecological condition.

What does the study involve?
Participants will undergo surgery as usual however, half of the participants will receive the saline infusion following the procedure and half will receive the normal after-care. Participants will be asked to fill in a questionnaire and asked to rate their pain after surgery.

What are the possible benefits and risks of participating?
There may or may not be any benefits. Information obtained from this study will help improve the treatment or management of other patients with the same disease or condition in the future.
During the study period, participants may experience nausea, vomiting, bloatedness, and abdominal discomfort post-operation, which are commonly experienced by most patients after surgery. Adequate painkiller and anti-vomiting medication will be given as per standard post-operative plan.

Where is the study run from?
University Malaya Medical Centre, Malaysia

When is the study starting and how long is it expected to run for?
July 2019 to December 2019

Who is funding the study?
investigator funded

Who is the main contact?
1. Prof. Aizura Syafinaz Ahmad Adlan,
aizuraadlan@gmail.com
2. Dr Hairel Mohd Tarmidzi,
hairel@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Aizura Syafinaz Ahmad Adlan

ORCID ID

Contact details

Obstetrics & Gynaecology Department
University Malaya Medical Centre
Jalan University
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+60123375808
aizuraadlan@gmail.com

Type

Public

Additional contact

Dr Hairel Mohd Tarmidzi

ORCID ID

Contact details

Obstetrics & Gynaecology Department
University Malaya Medical Centre
Jalan University
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+601112112522
hairel@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Version 1.0 01-01-2019

Study information

Scientific title

Post LaparoscopY Pain Reduction Project I (POLYPREP I): Single Strategy of Intraperitoneal Normal Saline Infusion (INSI); A Randomised Controlled Trial

Acronym

POLYPREP I

Study hypothesis

Intraperitoneal normal saline infusion would reduce post laparoscopy shoulder and abdominal pain

Ethics approval

Approved 20/03/2019, Medical Research Ethics Committee, University Malaya Medical Center (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; rosmawatib@ummc.edu.my; +603 79494422 ext. 3209 / 2251), ref: 201926-7106.

Study design

Randomised controlled trial single-blind

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Laparoscopic surgery

Intervention

Surgical procedure:
All procedures will be performed under general anaesthesia. Pre-operative prophylactic antibiotics will be given. Subjects will be put in Trendelenburg position at 20 degree with both arms tucked in. Carbon dioxide gas is used as the distension medium. Intra-abdominal pressure of 20 mmHg is achieved with a flow rate of 2L/min, followed by 5mm or 12mm primary trocar insertion at umbilicus. Additional ports are placed as necessary. The distension pressure is then reduced to 15mmHg with a flow rate not exceeding 2L/min throughout the surgery.

Intervention:
At the end of the surgery, the interventional protocols will be carried out as below:
Group A (INSI)
-Patient will be placed in Trendelenburg position (20 degrees). Intraperitoneal normal saline (15 ml/kg) will be infused at the upper part of the abdominal cavity evenly by the surgeon.
-Trocar sleeve valves will be left open during instillation of normal saline to allow carbon dioxide to escape from the abdominal cavity (this procedure usually lasts for approximately 5 minutes).
-The instilled normal saline will be left in-situ.
-Patient will be placed in neutral position at the end of the intervention.

Group B (control)
-Patient will be placed in Trendelenburg position (20 degrees).
-Trocar sleeve valves will be left open for a fixed time of 5 minutes.
-Patient will be placed in a neutral position at the end of the intervention.

After completing the intervention as stated above, instruments and trocars will be removed and abdominal incisions will be closed as per standard procedure. Subjects will receive standard postoperative care in ward and discharged according to the discretion of each managing team.

Subjects will be assigned to two groups at 1:1 ratio using a random-permuted block randomisation algorithm via web-based system (www.randomization.com) by an investigator not involved in subject recruitment. The master list for the randomised treatment allocation sequence will be kept by the same investigator. Concealment will be done by using serially numbered opaque, sealed envelopes; each of these envelopes contained a colour coded paper with the legend ‘INSI’ or control. The next available randomisation number will be assigned to the subject once she consents to participate (during pre-op discussion). The mentioned envelope will be given to study nurses who are not involved in the management of subject upon arrival inside theatre. The envelope will be opened at the end of the surgery, before removal of laparoscopic trocars in the operating room.

Subjects who withdraw from the study before surgery will be replaced by the next consented subject. However subjects who withdraw from the study after surgery will be counted as a dropout and no replacement will be done.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Post laparoscopy pain in shoulder and abdomen (upper and lower abdomen) area at 24, 48 and 72 hours after surgery using numeric rating scale (NRS).

Secondary outcome measures

1. Post operative use of analgesia
2. Nausea, vomiting and abdominal distension
3. Time to pass first flatus after surgery
4. Duration of hospital stay

Overall trial start date

01/01/2019

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women aged 18 years and above
2. Scheduled for laparoscopic surgery for benign gynaecological condition
3. American Society of Anaesthesiologist (ASA) classification I-II:
ASA I – normal healthy patient
ASA II – patient with mild systemic disease without substantive functional limitations (BMI < 40 kg/m2, well-controlled diabetes mellitus / mild hypertension, mild lung disease)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

68

Participant exclusion criteria

1. Conversion to laparotomy
2. Allergy to non-steroidal anti-inflammatory drugs (NSAID) drugs or paracetamol
3. Pre-operative emphysema / chronic obstructive pulmonary disease (COPD)
4. Women who do not understand the questionnaire
5. Pre-existing shoulder pain
6. Intellectual disability

Recruitment start date

01/07/2019

Recruitment end date

31/12/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

University Malaya Medical Centre
Obstetrics & Gynaecology Department University Malaya Medical Centre Jalan Universiti Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

Obstetrics & Gynaecology Department

Sponsor details

University Malaya Medical Centre
Jalan Universiti
Lembah Pantai
Kuala Lumpur
50603
Malaysia
+603-7949 4422
szawiah@um.edu.my

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/12/2019

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

25/06/2019: Trial’s existence confirmed by Medical Research Ethics Committee (MREC) University Malaya Medical Centre.