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Patient Satisfaction and Postoperative Pain After Diagnostic Hysteroscopy: Spinal Versus General Anesthesia

H

Hopital Charles Nicolle

Status

Completed

Conditions

Postoperative Pain
Patient Satisfaction
Hysteroscopy

Treatments

Procedure: Group GA: post operative pain scores and patient satisfaction evaluations

Study type

Interventional

Funder types

Other

Identifiers

NCT07358624
Charles Nicolle Hospital

Details and patient eligibility

About

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%.

Full 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.

Participants Adult women (≥18 years) scheduled for diagnostic hysteroscopy were screened during the pre-anesthetic consultation.

Randomization and Blinding:

Eligible patients were randomly assigned to one of two groups: general anesthesia (GA group) or spinal anesthesia (SA group). Randomization was performed preoperatively. Patients were blinded to the anesthetic technique used, whereas the anesthesiologist was not.

Anesthetic Management:

General Anesthesia: Patients in the GA group received preoxygenation followed by intravenous induction with fentanyl (approximately 3 μg/kg) and propofol (approximately 3 mg/kg). A supraglottic airway device (I-gel®) was inserted once adequate depth of anesthesia was achieved. Mechanical ventilation was provided in volume-controlled mode with lung-protective settings. Anesthesia was maintained with a continuous propofol infusion adjusted to achieve a Ramsay sedation score of 5. Intravenous paracetamol (1 g) was administered intraoperatively for postoperative analgesia. The supraglottic airway was removed after recovery of protective airway reflexes.

Spinal Anesthesia: In the SA group, spinal anesthesia was performed under aseptic conditions at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle. After confirmation of free cerebrospinal fluid flow, a mixture of hyperbaric bupivacaine 0.5% (8 mg) and sufentanil (2.5 μg) was injected intrathecally. Oxygen was administered via nasal cannula at 2 L/min. Surgery was initiated once a sensory block level of at least T10 was achieved.

Perioperative Monitoring and Management:

Standard monitoring included non-invasive blood pressure, continuous electrocardiography, pulse oximetry, and temperature measurement and (with respiratory parameters in GA groupe). Hypotension (defined as a decrease ≥20% from baseline) was treated with intravenous ephedrine boluses, and bradycardia (HR ≤ 50 beats/min) was treated with atropine as needed. Perioperative complications were recorded.

Postoperative Management and Outcomes:

All patients were transferred to the post-anesthesia care unit (PACU). Postoperative pain was assessed using the Numeric Rating Scale (NRS) in the PACU, on postoperative day 1, and day 2. Analgesic consumption and anesthesia-related adverse events were recorded. Patient satisfaction with anesthesia was evaluated before discharge using the Iowa Satisfaction with Anesthesia Scale (ISAS). Discharge readiness from the PACU was assessed using the modified Aldrete score, and readiness for home discharge was evaluated using the Post-Anesthetic Discharge Scoring System (PADSS).

Primary outcomes : patient satisfaction and pain scores. Secondary outcomes: PACU discharge delays, home discharge delays, frequency of nausea and vomiting, headache and bladder globe.

- Statistical Analysis: Sample size calculation was based on previously published data comparing postoperative pain scores between anesthetic techniques, with a power of 80% and a significance level of 5%. Data were analyzed using IBM SPSS Statistics (version 26). Continuous variables were expressed as mean ± standard deviation and compared using Student's t-test or the Mann-Whitney U test, as appropriate. Categorical variables were expressed as frequencies and percentages and compared using the chi-square test or Fisher's exact test. Multivariate logistic regression analysis was performed to identify factors independently associated with postoperative pain and patient satisfaction. A p value ≤0.05 was considered statistically significant.

Enrollment

84 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

84 participants in 2 patient groups

Group GA: General anesthesia
Active Comparator group
Description:
Group GA: patients undergoing diagnostic hysteroscopy under general anesthesia with an I-gel supraglottic airway and post operative pain scores and patient satisfaction evaluation
Treatment:
Procedure: Group GA: post operative pain scores and patient satisfaction evaluations
Group SA: Spinal anesthesia
Active Comparator group
Description:
Group SA: patients undergoing diagnostic hysteroscopy under spinal anesthesia and post operative pain scores and patient satisfaction evaluations
Treatment:
Procedure: Group GA: post operative pain scores and patient satisfaction evaluations

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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