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NCT05730751 Clinical Trial

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

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05730751
Other study ID # FMASU R213/2022
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date July 1, 2023

Study information
Verified date February 2024
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 44
Est. completion date July 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• spinal anesthesia
spinal anesthesia
• caesarean section
LSCS

Locations
Country Name City State
Egypt Ain shams university Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 intraoperative till 12 hours postoperative
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