Dexmedetomidine As An Adjuvant To Bupivacaine 0.1% in Labor Analgesia

NCT06550414 | Completed DMC

• 1 other identifier: HLH
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

Females who have experienced normal labor for child birth have claimed it to be most difficult and distressing moments of their life due to excruciating and unbearable pain. Provision of effective and satisfactory labor analgesia to the parturient helps in achieving greater degree of well-being for both mother and child. Several medical and non-medical pain relief methods are used since ages for pain relief during childbirth. Epidural anesthesia and intravenous opioids (pethidine) are most commonly offered to the mothers for relieving labor pain. So far, Epidural is considered gold standard in attaining maternal satisfaction for pain free deliveries. lt can be modified for individual parturient in order to achieve highest level of comfort and pain relief. To attain better and prolonged analgesia several additives have been used with local anesthetists and their effects are studied. Epidural opioids are conventionally being used as adjuvants, however associated side effects (nausea, vomiting, and pruritus) may limit their use. An alpha 2 adrenoceptor agonist, dexmedetomidine, has been effectively used and studied in labor epidurals and provided better analgesia without significant side effects. Hamed Lateef Hospital is one of the largest tertiary care private setup offering painless deliveries in Lahore. It is need of the hour to modify and improve our clinical practice in order to achieve highest level of patient satisfaction and provision of best possible maternal and fetal outcome. This study is proposed to investigate and elaborate the effect of adding dexmedetomidine to bupivacaine in labor epidurals and to study possible side-effects associated with its use.

Conditions

Labor Analgesia; Labor Pain

Keywords

bupivacaine; Dexmedetomidine; Labor analgesia

Outcome Measures

Primary Outcomes (1)

• onset of analgesia

  time noted for onset of analgesia in both groups

  Patient observed for 45 minutes after drug delivery and time required to achieve a VAS of 3 or less than 3 is noted down.

Study Arms (2)

bupivacaine group

PLACEBO COMPARATOR

group given 0.1% bupivacaine 10ml as loading dose in labor epidural.

Drug: Bupivacain

dexmedetomidine group

ACTIVE COMPARATOR

group given 50 micrograms of dexmedetomidine along with 0.1% bupivacaine in labor analgesia dose.

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Active comparator: dexmedetomidine group

Also known as: Labor analgesia

dexmedetomidine group

Bupivacain DRUG

Placebo comparator: bupivacaine group

Also known as: Labor analgesia

bupivacaine group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: 37 weeks or more pregnant female in active labor.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients in 37 or more weeks of pregnancy,
• having a single pregnancy with vertex presentation
• without any significant systemic disease will be included in the study.

You may not qualify if:

• Patients with mal-presentation
• twin pregnancy
• preeclampsia,
• uncontrolled systemic comorbidities
• diabetes, renal, hepatic, or cardiac.
• bleeding, diathesis, body mass index (BMl) more than 35 kg/m2
• known allergy to any of the study drugs will be excluded from the study.

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Hameed Lateef Hospital

Lahore, Punjab Province, 042, Pakistan

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Dexmedetomidine; Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Siddiq

  Hameed lateef hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: double blind.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: randomized control trial

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 13, 2024
• Study Start: November 1, 2022
• Primary Completion: April 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)