the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial
1 other identifier
interventional
110
1 country
1
Brief Summary
The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 7, 2013
CompletedFirst Posted
Study publicly available on registry
September 11, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 5, 2018
September 1, 2018
4.2 years
September 7, 2013
September 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative 12. hour VAS pain score
12 hour
Secondary Outcomes (1)
postoperative analgesic requırements
48 hours
Other Outcomes (1)
postoperative shoulder pain score
7 days
Study Arms (2)
maneuver group
EXPERIMENTALIn the intervention group, CO2 was removed by means of Trendelenburg position (30 degrees) and a pulmonary recruitment maneuver consisting of five manual inflations of the lung.
clasical group
NO INTERVENTIONno additional action will be taken after the operation
Interventions
Eligibility Criteria
You may qualify if:
- females aged 15-65 years,
- American Society of Anesthesiologists (ASA) physical status classification I-III
- no previous laparotomy(major abdominal surgery).
- need a laparascopic surgery
You may not qualify if:
- required hospitalization after the laparoscopic surgery,
- the procedure required conversion to laparotomy
- if a 48-hour follow-up was not feasible
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tepecik Education and Research Hospital
Izmir, 35120, Turkey (Türkiye)
Related Publications (2)
Esin S, Culha ZK, Kara OF, Yildirim H. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):380; author reply 380. doi: 10.1097/AOG.0b013e318182cb6e. No abstract available.
PMID: 18669740RESULTGungorduk K, Asicioglu O, Ozdemir IA. Effect of the pulmonary recruitment maneuver on pain after laparoscopic gynecological oncologic surgery: a prospective randomized trial. J Gynecol Oncol. 2018 Nov;29(6):e92. doi: 10.3802/jgo.2018.29.e92.
PMID: 30207100DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
isa aykut özdemir, m.d.
tepecik education and research hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Doctor
Study Record Dates
First Submitted
September 7, 2013
First Posted
September 11, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
September 5, 2018
Record last verified: 2018-09