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

Primary Purpose

Episiotomy Wound, Pain, Procedural

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Magnesium sulfate
Sponsored by
Rawalpindi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Episiotomy Wound

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Group B

    Group A

    Arm Description

    Patients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine only.

    Patients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine + 1 ml (500 mg) of 50% Magnesium sulphate

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2022
    Last Updated
    June 9, 2022
    Sponsor
    Rawalpindi Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05418114
    Brief Title
    Lignocaine Only Versus Lignocaine Plus Magnesium Sulphate for Pain Relief After Episiotomy.
    Official Title
    Comparison of Effect of Lignocaine Only Versus Lignocaine Plus Magnesium Sulphate as Adjuvant Perineal Pain Relief in Patients Undergoing Episiotomy.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    March 2023 (Anticipated)
    Study Completion Date
    April 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rawalpindi Medical College

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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. 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.
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Episiotomy Wound, Pain, Procedural

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    62 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group B
    Arm Type
    No Intervention
    Arm Description
    Patients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine only.
    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    Patients will be given local infiltration with 9 ml (180 mg) of 2% lignocaine + 1 ml (500 mg) of 50% Magnesium sulphate
    Intervention Type
    Drug
    Intervention Name(s)
    Magnesium sulfate
    Other Intervention Name(s)
    Magnesium sulphate
    Intervention Description
    . 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.
    Primary Outcome Measure Information:
    Title
    Pain Assessment
    Description
    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.
    Time Frame
    At episiotomy
    Other Pre-specified Outcome Measures:
    Title
    Pain Assessment
    Description
    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.
    Time Frame
    2 hours after episiotomy
    Title
    Pain Assessment
    Description
    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.
    Time Frame
    6 hours after episiotomy

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Pregnant ladies undergoing vaginal birth and willing to participate in the study. Exclusion Criteria: Patients not willing to participate in study. Patients with perineal hematoma, tear or other complications developed after episiotomy Patients requiring additional analgesia during treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hamna Atta, MBBS
    Phone
    +923354908127
    Email
    drhamna1027@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hamna Atta, MBBS
    Organizational Affiliation
    Rawalpindi Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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