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
About this trial
This is an interventional treatment trial for Episiotomy Wound
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.
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
NCT ID
NCT05418114
First Posted
February 24, 2022
Last Updated
June 9, 2022
Sponsor
Rawalpindi Medical College
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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Lignocaine Only Versus Lignocaine Plus Magnesium Sulphate for Pain Relief After Episiotomy.
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