Patient Satisfaction and Postoperative Pain After Diagnostic Hysteroscopy: A Randomized Controlled Study Comparing Spinal and General Anesthesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hopital Charles Nicolle
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Pain scores evaluation
Study Overview
Brief Summary
Background: Diagnostic hysteroscopy is a common ambulatory gynecological procedure that may be associated with perioperative discomfort and postoperative pain. The optimal anesthetic technique for improving patient comfort while ensuring rapid recovery remains controversial. This study aimed to compare spinal anesthesia and general anesthesia with a supraglottic airway in terms of postoperative pain and patient satisfaction following diagnostic hysteroscopy.
Methods: The investigators conducted a prospective, randomized, single-blind controlled study over a four-month period in a tertiary university hospital. After obtaining informed written consent, Adult women, American Society of Anesthesiologists (ASA) physical status of I, II, or stable III, without contraindications to spinal anesthesia, known allergy to anesthetic agents, full stomach, body mass index >35 kg/m², history of migraine or communication difficulties, scheduled for diagnostic hysteroscopy were randomly assigned to receive either general anesthesia with an I-gel supraglottic airway (GA group) or spinal anesthesia (SA group). Heart rate, non invasif blood pressure and pulse oxymetry are monitored. Postoperative pain was assessed using the Numeric Rating Scale (NRS) in the post-anesthesia care unit (PACU), on postoperative day 1 and day 2. Patient satisfaction with anesthesia was evaluated using the Iowa Satisfaction with Anesthesia Scale (ISAS). Secondary outcomes included recovery time, duration of stay in the PACU, and anesthesia-related complications.
Statistical study:
Data entry and analysis were performed by SPSS software version 26.0. We used Excel 2019 software to edit the charts. We retained a significance threshold for p less than 5%.
Detailed Description
BACKGROUND : Diagnostic hysteroscopy is widely performed as an ambulatory procedure to investigate abnormal uterine bleeding, infertility, and suspected intrauterine pathology. Despite being minimally invasive, it may generate discomfort and postoperative pain, particularly during cervical dilation and uterine distension. Choosing an anesthetic technique that optimizes patient comfort while preserving rapid recovery is therefore crucial.
General anesthesia with short-acting agents and supraglottic airway devices is commonly used in the operating room because it provides predictable conditions and fast emergence; however, it may be associated with postoperative nausea and vomiting and hemodynamic instability. Spinal anesthesia provides effective analgesia and stable surgical conditions, but may result in hypotension, urinary retention, post-dural puncture headache, and occasional failure requiring conversion to general anesthesia. Current evidence comparing these techniques in diagnostic hysteroscopy remains conflicting, and patient satisfaction-an important outcome in ambulatory care-has not been consistently evaluated.
This study compared spinal anesthesia and general anesthesia with a supraglottic airway in women undergoing diagnostic hysteroscopy, focusing on postoperative pain and patient satisfaction, as well as recovery outcomes and anesthesia-related adverse events.
Methods:
Study Design and Setting This prospective, randomized, single-blind controlled study was conducted over a four-month period, from September to December 2024, in the operating rooms of the Gynecology Departments A and B of Charles Nicolle University Hospital, Tunis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Investigator)
Masking Description
patients are randomly divided into two equal groups by an investigator not directly linked to the study
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •written informed consent.
- •an American Society of Anesthesiologists (ASA) physical status of I, II, or stable III in
- •women scheduled for diagnostic hysteroscopy
Exclusion Criteria
- •operative hysteroscopy.
- •contraindications to spinal anesthesia.
- •known allergy to anesthetic agents.
- •full stomach.
- •body mass index >35 kg/m².
- •history of migraine.
- •communication difficulties
- •Patients were excluded from the final analysis in case of:
- •spinal anesthesia failure requiring conversion to general anesthesia.
- •failure of ventilation with a supraglottic airway requiring tracheal intubation.
- •conversion to laparotomy.
- •prolonged hospitalization for non-anesthesia-related complications.
- •loss to follow-up after discharge.
Arms & Interventions
Group GA: General anesthesia
Group GA: patients undergoing diagnostic hysteroscopy under general anesthesia with an I-gel supraglottic airway and post operative pain scores and patient satisfaction evaluation
Intervention: Group GA: post operative pain scores and patient satisfaction evaluations (Procedure)
Group SA: Spinal anesthesia
Group SA: patients undergoing diagnostic hysteroscopy under spinal anesthesia and post operative pain scores and patient satisfaction evaluations
Intervention: Group GA: post operative pain scores and patient satisfaction evaluations (Procedure)
Outcomes
Primary Outcomes
Pain scores evaluation
Time Frame: Pain score was evaluated up to the second post operative day
Numeric Rating Scale (minimum =1 maximum =10; 1-3:mild pain; 4-7:moderate pain; 8-10:severe pain) in the post-anesthesia care unit (PACU), on postoperative day 1 and day 2 was evaluated
patient satisfaction
Time Frame: Iowa Satisfaction with Anesthesia Scale is evaluated in the post operative first hour (11 statements; usually 6 choices from "strongly disagree" to "strongly agree"were evaluated;
Patient satisfaction with anesthesia was evaluated using the Iowa Satisfaction with Anesthesia Scale (ISAS)
Secondary Outcomes
- anesthesia complications(anesthesia complications was recorded in the post operative first day)
- duration of stay in the PACU(duration of stay in the PACU was evaluated in the postopertive second hour)
- recovery time(ome discharge delays was evaluated in the postoperative first four hours)
Investigators
jebri alia
Head of anesthesia and intensive care departement
Hopital Charles Nicolle