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

NCT05418114 | Unknown Phase 4 DMC

• 1 other identifier: Obs/Gynae-1/HFH/RMU/16
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Episiotomy Wound; Pain, Procedural

Outcome Measures

Primary Outcomes (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.

  At episiotomy

Other Outcomes (2)

• Pain Assessment

  2 hours after episiotomy

• Pain Assessment

  6 hours after episiotomy

Study Arms (2)

Group B

NO INTERVENTION

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

Group A

ACTIVE COMPARATOR

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

Drug: Magnesium sulfate

Interventions

Magnesium sulfate DRUG

. 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.

Also known as: Magnesium sulphate

Group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

MeSH Terms

Conditions

Pain, Procedural

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Hamna Atta, MBBS

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hamna Atta, MBBS

CONTACT

+923354908127; drhamna1027@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Graduate Resident

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: June 14, 2022
• Study Start: September 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 14, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share