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

February 3, 2024 updated by: Adham Haggag, Ain Shams University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12245
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

parturients undergoing LSCS

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group F
The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 % and 25 µg fentanyl [6].
Procedure: spinal anesthesia
spinal anesthesia
Procedure: caesarean section
LSCS
Group C
The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 %
Procedure: spinal anesthesia
spinal anesthesia
Procedure: caesarean section
LSCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
intraoperative till 12 hours postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 16, 2023

Study Record Updates

Last Update Posted (Actual)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 3, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R213/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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