NCT06954896

Brief Summary

Background: Laparoscopic hysterectomy is one of the most frequently performed major surgeries in nonmalignant gynecological diseases. Effective postoperative analgesia is associated with short hospital stays, early mobilization, reduced costs, and patient satisfaction. Intravenous administration of nonsteroidal anti-inflammatory drugs, paracetamol or opioids; epidural catheter placement; peritoneal local anaesthetic administration; and superior hypogastric plexus block (SHPB) are routinely employed methods for postoperative pain management following laparoscopic hysterectomy. Methods: The study population comprised patients who underwent laparoscopic hysterectomy with or without oophorectomy for benign indications. A total of 94 patients were included in the study. Thirty patients received a superior hypogastric plexus block, thirty received intraperitoneal local anaesthetic spray, and thirty-four received intravenous analgesics. Conclusion: In the present study, a comparison of postoperative pain management in patients who underwent laparoscopic hysterectomy was conducted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 2, 2025

Completed
Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 14, 2025

Last Update Submit

April 30, 2025

Conditions

Keywords

Hypogastric PlexusHysterectomyIntraperitoneal Injections

Outcome Measures

Primary Outcomes (1)

  • VAS (vısual analog scale)

    For patients with no pain, VAS was recorded as 0 (zero), and for those with unbearable pain, VAS was recorded as 10 (ten).

    24 HOUR

Study Arms (3)

intraperitoneal local anaesthetic spray (Group B)

Drug: Intraperitoneal Bupivacaine spray

intravenous analgesics (Group C)

Drug: Dexketoprofen (KETAVEL 50 mg/2 ml)

superior hypogastric plexus block (Group S)

Drug: Bupivacain

Interventions

The superior hypogastric plexus block (SHPB) was performed following uterine removal and closure of the vaginal cuff, but prior to trocar removal from the abdominal cavity. The promontory was identified under laparoscopic visualization. The posterior peritoneum overlying the promontory was gently grasped and elevated with an instrument to create a peritoneal tent. A needle was then inserted at the apex of the tent and advanced approximately 1 cm. At this point, a subperitoneal space was further expanded using a surgical instrument, and 30 ml of 0.25% bupivacaine was injected into the area

superior hypogastric plexus block (Group S)

In cases where the VAS score exceeded 3 in the postoperative period, it was deemed that the patient's analgesia was insufficient, prompting the intravenous administration of 50 mg of dexketoprofen sodium.

intravenous analgesics (Group C)

The peritoneal cavity and abdominal wall were treated with 30 milliliters of 0.25% bupivacaine, with a focus on areas involving the peritoneum in the lower abdominal region.

intraperitoneal local anaesthetic spray (Group B)

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study population comprised patients who underwent laparoscopic hysterectomy-with or without oophorectomy-for benign indications (such as myoma uteri, dysfunctional uterine bleeding, uterine prolapse, or precancerous cervical lesions) between July 2024 and December 2024, and who were classified as ASA physical status I-II. Patients were excluded if they were younger than 18 or older than 65, underwent epidural catheterisation and/or received additional pain management modalities (e.g., transversus abdominis plane block, local wound infiltration, quadratus lumborum block), had surgery for malignancy, underwent a different surgical approach (e.g., transvaginal natural orifice transluminal endoscopic surgery), or were prescribed preoperative antidepressants or gabapentinoids.

You may qualify if:

  • patients who underwent laparoscopic hysterectomy-with or without oophorectomy-
  • ASA physical status I-II patients

You may not qualify if:

  • women with known bupivacaine allergy, anxiety-depressive disorders, fibromyalgia, coagulopathy, eclampsia/preeclampsia, or those who were pregnant were also excluded.
  • if they were younger than 18 or older than 65
  • underwent epidural catheterisation and/or received additional pain management modalities
  • prescribed preoperative antidepressants or gabapentinoids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mardin Artuklu University

Mardin, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Bupivacainedexketoprofen trometamol

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesiologist

Study Record Dates

First Submitted

April 14, 2025

First Posted

May 2, 2025

Study Start

July 1, 2024

Primary Completion

December 30, 2024

Study Completion

February 20, 2025

Last Updated

May 2, 2025

Record last verified: 2025-04

Locations