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Episiotomy WoundPhase 4NCT05418114

Lignocaine Only Versus Lignocaine Plus Magnesium Sulphate for Pain Relief After Episiotomy.

A Phase 4 study testing Magnesium sulfate in people with Episiotomy Wound and Pain, Procedural, run by Rawalpindi Medical College.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Trauma to perineal area is one of common problems faced by obstetricians affecting physical, social and mental wellbeing of patients. During labor, surgical incision to perineum (episiotomy) is done to facilitate delivery of fetus. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Episiotomy Wound, Pain, Procedural
What is being tested?
Magnesium sulfate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
No sites listed yet
Study dates
Sep 2022to Apr 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pregnant ladies undergoing vaginal birth and willing to participate in the study.

Who cannot join

  • Patients not willing to participate in study.
  • Patients with perineal hematoma, tear or other complications developed after episiotomy
  • Patients requiring additional analgesia during treatment.

Trial locations and contacts

No sites are listed yet.

Hamna Atta, MBBS contact

+923354908127

drhamna1027@gmail.com

About this study

Official title: Comparison of Effect of Lignocaine Only Versus Lignocaine Plus Magnesium Sulphate as Adjuvant Perineal Pain Relief in Patients Undergoing Episiotomy.

Trauma to perineal area is one of common problems faced by obstetricians affecting physical, social and mental wellbeing of patients. During labor, surgical incision to perineum (episiotomy) is done to facilitate delivery of fetus. Episiotomy is associated with complication such as hemorrhage, infection, pain and wound breakdown. Pain relief after episiotomy is primary concern of obstetrician and right of patient. Pain after delivery causes delayed mobility of patient, late initiation of breast feeding and may affect mother psychologically. Magnesium sulphate is readily available in obstetric units due to its diverse uses, wide safety margins and cost-effectiveness. Magnesium is a calcium channel blocker and noncompetitive N methyl D aspartate (NMDA) receptor antagonist with anti-nociceptive effects. Blocking of NMDA receptors inhibits central sensitization due to peripheral nociceptive stimulation. The role of magnesium has been evaluated as adjuvant for intra- and post-operative pain relief in orthopedic, gynecological, and thoracic surgeries and has established role in anesthesia and obstetrics. Lignocaine given locally does not provide adequate pain relief. There is need to find adjuvants to local anesthesia for pain relief after episiotomy. There is paucity of published data on the use of Magnesium sulphate as an adjunct to local anesthetics for episiotomy or its repair. No local study has been done in this regard.

Read the detailed description

Trauma to perineal area is one of common problems faced by obstetricians affecting physical, social and mental wellbeing of patients. (Perumal D. et al. 2017) During labor, surgical incision to perineum (episiotomy) is done to facilitate delivery of fetus. (Arulkumaran S. et al 2012) Episiotomy is associated with complication such as hemorrhage, infection, pain and wound breakdown. (Sule ST et al. 2003) Pain relief after episiotomy is primary concern of obstetrician and right of patient. (Brennan F. et al. 2007) Pain after delivery causes delayed mobility of patient, late initiation of breast feeding and may affect mother psychologically.

Suturing of episiotomy is done adhering to basic surgical principles of providing good pain control. (Sultan AH et al. 2014) Traditionally local analgesia using xylocaine is being used during episiotomy and repair. Despite this patients do complain of pain in postpartum period which seems less adequate for patients. One study compared infiltration of bupivacaine and lignocaine for episiotomy and found out that patients with lignocaine had higher pain score at 2, 4, and 6 h after the repair. (Abu-Zaida A. et al. 2021) One meta-analysis also determined that pain was lower with bupivacaine compared to lignocaine after episiotomy. (Fyneface Ogan S et al. 2006) Therefore it is necessary to determine other complementary methods to provide adequate pain relief after episiotomy.

Magnesium sulphate is readily available in obstetric units due to its diverse uses, wide safety margins and cost-effectiveness. Magnesium is a calcium channel blocker and noncompetitive N methyl D aspartate (NMDA) receptor antagonist with anti-nociceptive effects. Blocking of NMDA receptors inhibits central sensitization due to peripheral nociceptive stimulation. (Akhtar MI et al. 2011) Furthermore, there are peripheral NMDA receptors in the muscles, skin, and knee joints that play a role in sensory transmission of noxious signals. The nociceptors release glutamate in response to an afferent signal that binds to NMDA receptors leading to nerve depolarization and heightened sensitivity to circulating neurotransmitters. Magnesium sulphate inhibits these receptors thus producing anti-nociceptive effect. The addition of Magnesium sulphate to local anesthetics for neuraxial anesthesia prolongs the duration of anesthesia and improves the quality of analgesia. (Abd Elsalam KA et al. 2017)

The role of magnesium has been evaluated as adjuvant for intra- and post-operative pain relief in orthopedic, gynecological, and thoracic surgeries and has established role in anesthesia and obstetrics. (Akhtar MI et al. 2011) Moreover studies have determined that subcutaneous infiltration of Magnesium sulphate with local anesthetic after caesarean section prolongs the analgesic efficacy of local anesthetic without any significant adverse effects. (Kundra S et al. 2016) One recent study comparing the effects of using local infiltration of lignocaine only and lignocaine with magnesium after episiotomy sulfate determined that patients have significant pain relief after 2 hours with combination of lignocaine and magnesium sulfate. (Garba JA et al. 2021)

Being tested
Magnesium sulfate
Medical subject headings
Pain, Procedural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfateDrug

    Also called Magnesium sulphate

    . One group (Group A) will be given local infiltration with 9 ml (180 mg) of 2% lignocaine + 1 ml (500 mg) of 50% Magnesium sulphate. Other group (Group B) will be given local infiltration with 9 ml (180 mg) of 2% lignocaine.

Study groups in NCT05418114
Study groupRoleWhat they receive
Group BNo interventionPatients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine only.
Group AActive comparatorPatients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine + 1 ml (500 mg) of 50% Magnesium sulphate
Receives: Drug: Magnesium sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain Assessment

    Numeric rating scale (NRS) for pain assessment with score of 0 as "no pain" to 10 as "worst imaginable pain" will be used to assess pain.

    Measured: At episiotomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionMar 2023 (estimated)
  4. Study completionApr 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418114
Sponsor's protocol ID
Obs/Gynae-1/HFH/RMU/16
Status last verified
Jun 2022
First submitted
24 Feb 2022
Last updated
14 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium sulfate in people with Episiotomy Wound and Pain, Procedural, run by Rawalpindi Medical College.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hamna Atta, MBBS (+923354908127, drhamna1027@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Assessment (time frame: At episiotomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.

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