NCT05730751

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

February 5, 2023

Last Update Submit

February 3, 2024

Conditions

Shoulder Pain

Outcome Measures

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

    intraoperative till 12 hours postoperative

Study Arms (2)

Group F

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

Procedure: spinal anesthesiaProcedure: caesarean section

Group C

The patients will receive 2.5 ml of hyperbaric bupivacaine 0.5 %

Procedure: spinal anesthesiaProcedure: caesarean section

Interventions

spinal anesthesiaPROCEDURE

spinal anesthesia

Group CGroup F
caesarean sectionPROCEDURE

LSCS

Group CGroup F

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

parturients undergoing LSCS

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university

Cairo, 12245, Egypt

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Anesthesia, SpinalCesarean Section

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDelivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate proffesor

Study Record Dates

First Submitted

February 5, 2023

First Posted

February 16, 2023

Study Start

March 1, 2023

Primary Completion

June 1, 2023

Study Completion

July 1, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Locations

EG(1)