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

NCT05418114 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2022-06-14

No results posted yet for this study

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.

Conditions

  • Episiotomy Wound
  • Pain, Procedural

Interventions

DRUG

Magnesium sulfate

. 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.

Sponsors & Collaborators

  • Rawalpindi Medical College

    lead OTHER

Principal Investigators

  • Hamna Atta, MBBS · Rawalpindi Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-30
Primary Completion
2023-03-31
Completion
2023-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05418114 on ClinicalTrials.gov