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CompletedNCT05730751Updated Feb 6, 2024

Could Intrathecal Fentanyl Prevent Shoulder Tip Pain (STP) During and After Caesarean Section

An observational study in Shoulder Pain, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-02-06.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
44
Ages
18 Years to 35 Years
Sex
Female
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Study summary

Shoulder pain is a commonly observed, annoying and mostly neglected consequence of cesarean section and little is known as well as explored about intraoperative shoulder pain. This study will explore the factors precipitating shoulder pain during cesarean section, preventive analgesia and treatment modalities

Read the detailed description

The most common surgery performed on women around the world is caesarean section. The majority of caesarean sections these days are carried out under regional analgesia, though some need to be carried out under general anesthesia, particularly in emergency situations or when there is a contraindication to the use of regional anesthesia. Benefits of spinal anesthesia include an awake mother at birth, minimizing or avoiding the risk of general anesthesia (aspiration, difficulty intubation, etc.) and minimal side effects to the newborn.

Shoulder tip pain (STP) is a usual complication after laparoscopy with the incidence reported varying between35% to 80%. Recent studies suggest that this type of pain is also seen after cesarean section Shoulder pain is commonly observed, but is largely ignored complication of caesarean section, and little is understood or studied regarding intraoperative shoulder pain.

Shoulder pain can be more excruciating in some patients than the pain from the surgical incision. This pain may be associated with diaphragmatic irritation/injury from local acidosis, the irritating effects of carbon dioxide during pneumoperitoneum, or stretching forces on the diaphragm. ( Although carbon dioxide is not used in cesarean compared to laparoscopic surgeries, stretching forces on the diaphragm during cesarean can be one of the causes of shoulder pain in these patients.

It is believed that seepage of blood or amniotic fluid into the abdomen accumulation during cesarean section and subdiaphragmatic may be the cause of STP. Retained blood clots in patients undergoing CS can induce diaphragmatic discomfort and stimulate the phrenic nerve. Peritoneal cleaning and visceral manipulation also may play a part.

Fentanyl is a commonly used lipophilic opioid for spinal anesthesia with relatively approved intraoperative anti-nociceptors effect.

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Conditions studied

  • Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 44 is below the median of 82 across 130 observational studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Sampling method
Probability sample

Study population

parturients undergoing LSCS

Inclusion criteria

  • ASA physical status I-II,
  • uncomplicated, singleton pregnancies of at least 36 weeks gestation.

Exclusion criteria

Exclusion Criteria:

  • Cardiac, liver or renal disease
  • Allergy to amide local anesthetics
  • History of epilepsy or any other neurological problem
  • Any contraindication of regional anesthesia, or patient refusal
  • Intrauterine growth restriction or fetal compromise
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
44 participants (actual)
Patient registry
No

Groups and cohorts

  • Group F

    The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 % and 25 µg fentanyl \[6\].

    Procedure: spinal anesthesia · Procedure: caesarean section

  • Group C

    The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 %

    Procedure: spinal anesthesia · Procedure: caesarean section

Interventions

  • Procedurespinal anesthesia

    spinal anesthesia

  • Procedurecaesarean section

    LSCS

06

What researchers measure

Primary outcomes

  1. incidence of occurrence intraoperative and early postoperative shoulder tip pain anesthesia as a preventive analgesia for shoulder tips pain with Cesarean section.

    comparing incidence of shoulder pain between the groups

    Time frame: intraoperative till 12 hours postoperative

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Study locations

1 site
  • Ain shams university
    Cairo, 12245, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05730751
Lead sponsor
Ain Shams University
Responsible party
Adham Haggag (Associate proffesor, Ain Shams University) — Principal investigator
First posted
Feb 16, 2023
Start date
Mar 1, 2023
Primary completion
Jun 1, 2023
Completion
Jul 1, 2023
Last update
Feb 6, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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