Comparison between injection of local analgesia and performing a specific nerve block in the management of vaginal pain after delivery
| ISRCTN | ISRCTN16535250 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16535250 |
| Secondary identifying numbers | 20092018 |
- Submission date
- 23/09/2020
- Registration date
- 24/01/2021
- Last edited
- 04/02/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Episiotomy or tearing of perineal tissues during childbirth is associated with significant pain in the postpartum period. Although the use of episiotomy is often debated, it remains the most common surgical procedure experienced by women. Pain from episiotomy is poorly treated, though it may be severe and can result in significant discomfort and interference with basic daily activities and adversely impact motherhood experiences.
Furthermore, episiotomy may increase the risk of chronic perineal pain, which is estimated to occur in 13% to 23% of women after episiotomy. Before the widespread use of epidural anesthesia in obstetrics, pudendal nerve block (block of the nerve supply of the perineum) was a commonly used anesthetic technique for vaginal birth reported as early as 1908. Pudendal nerve block became popular in the mid-1950s and was often used as anesthesia for childbirth into the mid-1980s. As epidural use grew in popularity, pudendal nerve block declined in the United States.
The aim of this study is to assess the effect of pudendal nerve block on pain relief after episiotomy compared to local injection of anesthesia.
Who can participate?
Women giving birth at Ain Shams University maternal Hospital in Cairo, Egypt
What does the study involve?
Women are randomly allocated to receive either pudendal nerve block or local injection of anesthesia and then the two groups are compared in terms of pain after episiotomy for the first 6 hours after delivery.
What are the possible benefits and risks of participating?
A possible benefit is to show the useful effect of pudendal nerve block in the management of post episiotomy pain relief. Possible complications are the known complications of pudendal nerve block such as injury of blood vessels or nerves.
Where is the study run from?
Ain Shams University Maternal Hospital (Egypt)
When is the study starting and how long is it expected to run for?
July 2018 to February 2019
Who is funding the study?
Ain Shams University Hospital (Egypt)
Who is the main contact?
Abdelrahman Abouelhassan
bodym93@yahoo.com
Contact information
Public
Hindenburgstrasse 15
Hagen
58095
Germany
| Phone | +49 (0)1632042180 |
|---|---|
| bodym93@yahoo.com |
Study information
| Study design | Single-center interventional randomized controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet |
| Scientific title | Effect of pudendal nerve block versus perineal local infiltration of analgesia in post episiotomy pain relief |
| Study objectives | In women in labor and undergoing episiotomy pudendal nerve block may be similar to local infiltration by analgesic as regard post episiotomy pain relief. |
| Ethics approval(s) | Approved 20/09/2018, board of the department of obstetrics and gynecology, Ain Shams University (Ramsis St., Abbaseya, 11517 Cairo, Egypt; +20 (0)2 24346347; medicom@med.asu.edu.eg), ref: not provided |
| Health condition(s) or problem(s) studied | Post episiotomy pain after delivery |
| Intervention | Random allocation sequence generation: a computer-generated list via MedCalc software version 13.2.2 is used, assigning each patient to a study group. Pudendal nerve block is performed when the cervix is fully dilated with vertex station +1 to +2 using 5 ml Bupivacaine hydrochloride 0.25% (Marcaine®; 0.25%, 5 ml) plus 0.5ml dexamethasone dihydrogen phosphate 8 mg (Fortecortin® 8 mg, 0.5 ml). The other group of patients undergo local perineal infiltration of analgesia for post episiotomy pain relief. Follow up of pain score is performed up to 6 hours postpartum. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain measured using the Visual Analogue Scale assessed every hour for the first 6 hours postpartum starting from the time of the analgesia injection |
| Secondary outcome measures | 1. Need for analgesics assessed by asking the patient every hour for the first 6 hours postpartum starting from the time of the analgesia injection 2. Delivery time (minutes) after injection of analgesia, documented at the time of delivery 3. Pregnancy outcome assessed using Apgar score at 1 and 5 min after delivery |
| Overall study start date | 21/07/2018 |
| Completion date | 21/02/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | 1. Primigravida 2. Singleton term pregnancy 3. Age (20-35 years) 4. Free of medical disorders |
| Key exclusion criteria | 1. Presence of infection 2. Coagulation abnormalities 3. History of sensitivity to local anesthetics 4. Malpresentation or malposition 5. Previous vaginal operations and or presence of any obstetric complications |
| Date of first enrolment | 20/09/2018 |
| Date of final enrolment | 20/02/2019 |
Locations
Countries of recruitment
- Egypt
Study participating centre
Ramsis St., Abbaseya
Cairo
11517
Egypt
Sponsor information
University/education
Faculty of Medicine
Ramsis St., Abbaseya
Cairo
11517
Egypt
| Phone | +20 (0)2 24346347 |
|---|---|
| medicom@med.asu.edu.eg | |
| Website | http://www.asu.edu.eg/ |
"ROR" |
https://ror.org/00cb9w016 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Abdelrahman Abouelhassan (Bodym93@yahoo.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/02/2021 | No | No |
Additional files
- ISRCTN16535250_PROTOCOL.pdf
- uploaded 04/02/2021
Editorial Notes
04/02/2021: Uploaded protocol (not peer reviewed) Version n/a, no date.
09/11/2020: Trial's existence confirmed by Ain Shams University.
