Skip to main content
OpenTrials
Completed

NCT Number: NCT05730751

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

Ain shams university

Cairo, 12245, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Spinal anesthesia

Procedure

spinal anesthesia

Caesarean section

Procedure

LSCS

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.

    Time frame: intraoperative till 12 hours postoperative

    comparing incidence of shoulder pain between the groups

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 16, 2023
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.