Role of analgesia given in the peritoneum and through the site of wound before the end of operation in patients undergoing removal of undescended uterus through the vaginal route

ISRCTN ISRCTN59760944
DOI https://doi.org/10.1186/ISRCTN59760944
Secondary identifying numbers 563476
Submission date
23/02/2017
Registration date
07/03/2017
Last edited
07/03/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Eman Omran
Scientific

Department of Obstetrics and Gynecology
Faculty of Medicine
Al-Saray Street
Cairo
11956
Egypt

Phone +20 22 3682030
Email eman.omran@kasralaini.edu.eg

Study information

Study designDouble-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet No participant information sheet available
Scientific titleRole of ropivacaine postincisional infiltration with intraperitoneal instillation analgesia in postoperative pain relief in patients undergoing non descent vaginal hysterectomy: Randomized controlled trial
Study objectivesThe 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(s)Internal Ethical Committee of Department of Obstetrics and Gynecology, 10/12/2013, ref: 344561
Health condition(s) or problem(s) studiedNon descent vaginal hysterectomy
InterventionParticipants 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ropivacaine
Primary outcome measurePain is measured using the visual analogue score at 0.5, 1, 2, 4, 8, 12 and 24 hours post-operatively.
Secondary outcome measures1. 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 study start date01/11/2013
Completion date15/04/2016

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsMinimum of 42
Key inclusion criteria1. Female
2. 45 to 70 years old
3. Scheduled for NDVH for benign indications without need for oophorectomy or vaginal reconstructive surgery
Key exclusion criteria1. 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
Date of first enrolment20/01/2014
Date of final enrolment10/01/2016

Locations

Countries of recruitment

  • Egypt

Study participating centre

Benha University Hospital
Fareed Nada Street
Benha
13511
Egypt

Sponsor information

Benha University
University/education

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

ROR logo "ROR" https://ror.org/03tn5ee41

Funders

Funder type

University/education

Benha University

No information available

Results and Publications

Intention to publish date31/12/2017
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
IPD sharing planThe current data sharing plans for the current study are unknown and will be made available at a later date.