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

NCT07358624 | Completed

• 1 other identifier: Charles Nicolle Hospital
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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%.

Conditions

Hysteroscopy; Patient Satisfaction; Postoperative Pain

Keywords

Diagnostic hysteroscopy; postopertive pain; patient satisfaction; anesthesia complications

Outcome Measures

Primary Outcomes (2)

• Pain scores evaluation

  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

  Pain score was evaluated up to the second post operative day

• patient satisfaction

  Patient satisfaction with anesthesia was evaluated using the Iowa Satisfaction with Anesthesia Scale (ISAS)

  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;

Secondary Outcomes (3)

• 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

Study Arms (2)

Group GA: General anesthesia

ACTIVE COMPARATOR

Group GA: patients undergoing diagnostic hysteroscopy under general anesthesia with an I-gel supraglottic airway and post operative pain scores and patient satisfaction evaluation

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

Group SA: Spinal anesthesia

ACTIVE COMPARATOR

Group SA: patients undergoing diagnostic hysteroscopy under spinal anesthesia and post operative pain scores and patient satisfaction evaluations

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

Interventions

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

* 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)

Group GA: General anesthesia; Group SA: Spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• written informed consent.
• an American Society of Anesthesiologists (ASA) physical status of I, II, or stable III in
• women scheduled for diagnostic hysteroscopy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Charles Nicolle: lead

Study Sites (1)

Charles Nicolle hospital Tunis

Bab Saadoun, Tunis, 1006, Tunisia

Location

Related Publications (6)

• Nzau-Ngoma E, Odimba M, Kusuman A, Mboloko E. Office hysteroscopy: findings in patients attending a clinic in Kinshasa. The international society of endoscopic gynecology. 2022;

  BACKGROUND

• Samy A, Nabil H, Abdelhakim AM, Mahy ME, Abdel-Latif AA, Metwally AA. Pain management during diagnostic office hysteroscopy in postmenopausal women: a randomized study. Climacteric. 2020 Aug;23(4):397-403. doi: 10.1080/13697137.2020.1742685. Epub 2020 Apr 17.

  PMID: 32299254 BACKGROUND

• Manouchehrian N, Pilehvari S, Rahimi-Bashar F, Esna-Ashari F, Mohammadi S. Comparison of the effects of spinal anesthesia, paracervical block and general anesthesia on pain, nausea and vomiting, and analgesic requirements in diagnostic hysteroscopy: A non-randomized clinical trial. Front Med (Lausanne). 2023 Mar 1;10:1089497. doi: 10.3389/fmed.2023.1089497. eCollection 2023.

  PMID: 36936226 BACKGROUND

• The Use of Hysteroscopy for the Diagnosis and Treatment of Intrauterine Pathology: ACOG Committee Opinion, Number 800. Obstet Gynecol. 2020 Mar;135(3):e138-e148. doi: 10.1097/AOG.0000000000003712.

  PMID: 32080054 BACKGROUND

• Stefanescu A, Marinescu B. Diagnostic hysteroscopy - a retrospective study of 1545 cases. Maedica (Bucur). 2012 Dec;7(4):309-14.

  PMID: 23483793 BACKGROUND

• Centini G, Troia L, Lazzeri L, Petraglia F, Luisi S. Modern operative hysteroscopy. Minerva Ginecol. 2016 Apr;68(2):126-32. Epub 2016 Mar 1.

  PMID: 26930389 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Pain, Postoperative

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Alia Jebri, MD

  Charles Nicolle Hospital Tunis

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: patients are randomly divided into two equal groups by an investigator not directly linked to the study
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of anesthesia and intensive care departement

Model Details: GA Group: patients undergoing diagnostic hysteroscopy under general anesthesia with an I-gel supraglottic airway. SA Group: patients undergoing diagnostic hysteroscopy under spinal anesthesia

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 22, 2026
• Study Start: September 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: January 10, 2025
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)