Condition category
Surgery
Date applied
23/02/2017
Date assigned
07/03/2017
Last edited
07/03/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A hysterectomy is a surgical procedure to remove the womb (uterus). This can be done in a number of ways, including through a cut in the top of the vagina (vaginal hysterectomy), through a cut in the lower tummy (abdominal hysterectomy) or through several small cuts in the tummy (laparoscopic hysterectomy). There are many reasons for undergoing a hysterectomy, including cancer and non-cancerous conditions of the female reproductive system. Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.

Who can participate?
Women aged between 45 and 70 who are having a vaginal hysterectomy.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given infections of a fluid in the same places that offers no pain relief (salt water) before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay is recorded.

What are the possible benefits and risks of participating?
There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.

Where is the study run from?
Benha University Hospital (Egypt)

When is the study starting and how long is it expected to run for?
November 2013 to April 2016

Who is funding the study?
Benha University (Egypt)

Who is the main contact?
Dr Eman Omran
eman.omran@kasralaini.edu.eg

Trial website

Contact information

Type

Scientific

Primary contact

Dr Eman Omran

ORCID ID

Contact details

Department of Obstetrics and Gynecology
Faculty of Medicine
Al-Saray Street
Cairo
11956
Egypt
+20 22 3682030
eman.omran@kasralaini.edu.eg

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

563476

Study information

Scientific title

Role of ropivacaine postincisional infiltration with intraperitoneal instillation analgesia in postoperative pain relief in patients undergoing non descent vaginal hysterectomy: Randomized controlled trial


Acronym

Study hypothesis

The aim of this study is to establish whether ropivacaine postincisional infiltration with intraperitoneal instillation analgesia is effective in providing postoperative pain relief in patients undergoing non-descent vaginal hysterectomy.

Ethics approval

Internal Ethical Committee of Department of Obstetrics and Gynecology, 10/12/2013, ref: 344561

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Non descent vaginal hysterectomy

Intervention

Participants are randomised to one of two groups in a 1:1 ratio using computer generated block randomisation.

Intervention group: Participants are given ropivacaine at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum before the end of operation as pre-emptive analgesia.

Control group: Participants are given a fluid injection of saline at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum before the end of operation.

Participants in both groups are assessed for side-effects and pain levels 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.

Intervention type

Drug

Phase

Not Applicable

Drug names

Ropivacaine

Primary outcome measures

Pain is measured using the visual analogue score at 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.

Secondary outcome measures

1. Time in hours to get out of bed after operation is measured by nurse responsible for the patient at 8 and 12 hours post-operatively
2. Hospital stay in days is measured by nurse at time of discharge of the patient
3. Total Narcotic dose (Nalbuphine) is measured by nurse at 1 and 24 hours post-operatively
4. Total parentral NSAID (diclofenac sodium) used in the first 24 hours after surgery is measured by nurse at 24 hours post-operatively
5. Number and proportion of patients with nausea and vomiting in the first 24 hours is measured by nurse at 24 hours post-operatively
6. Time spent in the post-anethesia care unit is measured by nurse at time of discharge from the post-anethesia care unit

Overall trial start date

01/11/2013

Overall trial end date

15/04/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. 45 to 70 years old
3. Scheduled for NDVH for benign indications without need for oophorectomy or vaginal reconstructive surgery

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Minimum of 42

Participant exclusion criteria

1. Patient weight less than 50 kg
2. Allergy to amide local anathetic
3. Dementia or mental retardation to a degree which would interfere with data collection
4. Contraindication to non descent vaginal hysterectomy

Recruitment start date

20/01/2014

Recruitment end date

10/01/2016

Locations

Countries of recruitment

Egypt

Trial participating centre

Benha University Hospital
Fareed Nada Street
Benha
13511
Egypt

Sponsor information

Organisation

Benha University

Sponsor details

Department of Obstetrics and Gynecology
Benha University Hospital
El-Shaheed Farid Nada
Qism Banha
Al Qalyubia Governorate
Benha
13511
Egypt

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Benha University

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 plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2017

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes