Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor

NCT ID: NCT06823349

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-07-31

Brief Summary

the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.

Detailed Description

on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.

parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine.

Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared.

Conditions

Vaginal Delivery; Normal Labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dexmedetomidine

the investigators give 5 mic of dexmedetomidine (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine

fentanyl

the investigators give 25 mic of fentanyl (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Group Type: ACTIVE_COMPARATOR

fentanyl

Intervention Type: DRUG

25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine

Bupivacaine only

the investigators give 0.5 ml saline 0.9% added to 2.5 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Group Type: PLACEBO_COMPARATOR

Saline 0.9%

Intervention Type: DRUG

0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine

Interventions

Dexmedetomidine

5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine

Intervention Type: DRUG

fentanyl

25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine

Intervention Type: DRUG

Saline 0.9%

0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ASA I-II.
• Uncomplicated pregnancy.
• At term & singleton fetus.
• Cervical dilatation > 5cm
• Cephalic presentations

Exclusion Criteria

• Patient refusal.
• Bleeding disorders and patients on anticoagulant drugs.
• Infection at site of injection.
• Spine deformity.
• Allergy to any of study medications.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Jehan George Sadek

OTHER

Sponsor Role: lead

Responsible Party

Jehan George Sadek

resident doctor at anesthesia, surgical intensive care unit and pain management department at Aswan University hospital.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Aswan University Hospital

Aswān, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Jehan G Younan, resident doctor.

Role: CONTACT

jehan.younan1995@gmail.com

+20 01222333194

Other Identifiers

Asw.Uni. / 926 / 5 / 24

Identifier Type: -

Identifier Source: org_study_id