Dexmedetomidine vs Fentanyl in Controlling Labor Pain

Labor Pain Clinical Trial

Official title:

Dexmedetomidine Versus Fentanyl as an Adjuvant to Single Low Dose Spinal Anesthesia in Controlling Labor Pain: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06392321
• Other study ID #: controlling labor pain
• Status: Completed
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Fentanyl
comparison between bupivacaine, bupivacaine and fentanyl.
• Dexmedetomidine
comparison between bupivacaine, bupivacaine and dexmedetomidine..

Locations

Country	Name	City	State
Egypt	Al Azhar University	Cairo	Naser City

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of intrathecal dexmedetomidine	VAS	120 minutes
Secondary	patient satisfaction	satisfaction score	2 hours
Secondary	mother's outocme	APGAR	1 and 5 minutes