Comparison Between Hyperbaric Bupivacaine With Fentanyl vs. Hyperbaric Bupivacaine With Dexmedetomidine in Reducing Visceral Pain During Cesarean Delivery Under Spinal Anaesthesia

NCT06367660 | Not Yet Recruiting Phase 4

• 1 other identifier: 98-2024
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale

Conditions

Visceral Pain

Outcome Measures

Primary Outcomes (1)

• Primary outcome

  To compare the incidence of intraoperative visceral pain between participants of two groups.

  Intraoperative

Secondary Outcomes (1)

• Secondary Outcome

  Intraoperative

Study Arms (2)

Bupivacaine with Fentanyl (BF)

ACTIVE COMPARATOR

In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml . Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.

Drug: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine

Bupivacaine with Dexmedetomidine (BD)

ACTIVE COMPARATOR

In patients undergoing elective LSCS under subarachnoid block, group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.

Drug: Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine

Interventions

Intrathecal Bupivacaine-Fentanyl and Bupivacaine-Dexmedetomidine DRUG

In patients undergoing elective LSCS under subarachnoid block, group BF will receive 0.5% hyperbaric bupivacaine 10mg (2ml) with fentanyl 10 mcg (0.2ml) with total of 2.2 ml and group BD will receive 0.5% hyperbaric bupivacaine 10 mg with Dexmedetomidine 5mcg (0.2ml) total volume 2.2ml. Assessment of intraoperative visceral pain will be done by self-reporting of patients, who are previously educated, as poorly localized discomfort or dragging, pulling heaviness or unpleasant feeling or pain with or without nausea and will be categorized according to preformed scale.

Bupivacaine with Dexmedetomidine (BD); Bupivacaine with Fentanyl (BF)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant female planned for elective C-section
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective caesarean deliveries under SAB
• ASA PS II
• Age ≥18 years
• Term pregnancy ≥37 weeks of gestation
• Height ≥ 150

You may not qualify if:

• Patients with medical disorder in pregnancy (neurological, psychiatric, cardiopulmonary,
• hepatorenal diseases, coagulopathy)
• Patient refusal to participate
• Allergy or hypersensitivity to LA, fentanyl or dexmedetomidine
• Patients with communication problem
• Patient with bradycardia (HR- less than 60)

Sponsors & Collaborators

• Tribhuvan University Teaching Hospital, Institute Of Medicine.: lead

Related Publications (1)

• Dhakal S, Shrestha M, Gautam E, Suwal A, Dhakal S, Dhakal S. Comparison of hyperbaric bupivacaine with fentanyl vs. hyperbaric bupivacaine with dexmedetomidine in reducing visceral pain during cesarean delivery under spinal anesthesia: study protocol. Pain Manag. 2025 Oct;15(10):651-658. doi: 10.1080/17581869.2025.2543232. Epub 2025 Aug 6.

  PMID: 40765391 DERIVED

MeSH Terms

Conditions

Visceral Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Sujan Dhakal

  Ministry of health and population

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sujan Dhakal

CONTACT

9851325896; szndkl44@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthesiologist

Model Details: Research method: Quantitative Type of study: Randomized, interventional, comparative study

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: April 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share