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Dexmedetomidine vs Fentanyl in Controlling Labor Pain

NCT ID: NCT06392321

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-12-31

Brief Summary

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As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.

Detailed Description

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Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).

Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).

Conditions

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Labor Pain

Keywords

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Dexmedetomidine Fentanyl intrathecal labor pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fentanyl

Bupivacaine 3,75 mg + 2.5 ml saline added to fentanyl 20 microgram + 2.3 ml saline

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

comparison between bupivacaine, bupivacaine and fentanyl.

Dexmedetomidine

Bupivacaine 3,75 mg + 2.5 ml saline added to dexmedetomedine 5 microgram + 2.3 ml saline

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

comparison between bupivacaine, bupivacaine and dexmedetomidine..

control

Bupivacaine 3,75 mg + 2.5 ml saline

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fentanyl

comparison between bupivacaine, bupivacaine and fentanyl.

Intervention Type DRUG

Dexmedetomidine

comparison between bupivacaine, bupivacaine and dexmedetomidine..

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* women planned for spontaneous vaginal delivery.

Exclusion Criteria

* cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ismail Mohamed Abdelgawad Ahmed

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al Azhar University

Cairo, Naser City, Egypt

Site Status

Countries

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Egypt

References

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Lupu VV, Miron IC, Raileanu AA, Starcea IM, Lupu A, Tarca E, Mocanu A, Buga AML, Lupu V, Fotea S. Difficulties in Adaptation of the Mother and Newborn via Cesarean Section versus Natural Birth-A Narrative Review. Life (Basel). 2023 Jan 21;13(2):300. doi: 10.3390/life13020300.

Reference Type BACKGROUND
PMID: 36836657 (View on PubMed)

Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.

Reference Type BACKGROUND
PMID: 30237594 (View on PubMed)

Shrestha IK, Chalise R, Poudel S, Regmi A, Ghimire A, Khadka B, Khanal K. Neostigmine and atropine as a treatment for postdural puncture headache after spinal anesthesia in cesarean section: A case report. Clin Case Rep. 2023 Nov 2;11(11):e8132. doi: 10.1002/ccr3.8132. eCollection 2023 Nov.

Reference Type BACKGROUND
PMID: 37927977 (View on PubMed)

Show KL, Ngamjarus C, Kongwattanakul K, Rattanakanokchai S, Duangkum C, Bohren MA, Betran AP, Somjit M, Win WYH, Lumbiganon P. Fentanyl for labour pain management: a scoping review. BMC Pregnancy Childbirth. 2022 Nov 17;22(1):846. doi: 10.1186/s12884-022-05169-x.

Reference Type BACKGROUND
PMID: 36397024 (View on PubMed)

Other Identifiers

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controlling labor pain

Identifier Type: -

Identifier Source: org_study_id