Comparison of the Effects of Blocks on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery

NCT ID: NCT07078643

Last Updated: 2025-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-03-31

Brief Summary

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Total laparoscopic hysterectomy (TLH) is one of the most commonly performed gynecological surgeries today. Various analgesic techniques are used for the management of postoperative pain. The aim of this study is to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) in patients undergoing TLH procedures.

Detailed Description

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This prospective, randomized, double-blind, single-center clinical trial aims to compare the postoperative analgesic efficacy of Superior Hypogastric Plexus Block (SHPB) and Erector Spinae Plane Block (ESPB) in patients undergoing total laparoscopic hysterectomy (TLH).

Following ethics committee approval (2022/514/220/10), the study was conducted between March 2022 and March 2023. Patients aged 18 to 65 years, classified as ASA physical status I-II and scheduled for elective TLH, were enrolled. Participants were randomly assigned into three groups using computer-generated randomization (n=30 per group): SHPB, ESPB, and Control. Both the anesthesiologist performing postoperative evaluations and the patients were blinded to group allocation.

All patients received general anesthesia in accordance with a standardized protocol.

ESPB was performed bilaterally at the T10 level under ultrasound guidance. SHPB was performed laparoscopically at the L5-S1 level after uterine removal. No regional block was applied in the control group.

Postoperative pain management was provided to all patients via patient-controlled analgesia (PCA). Pain levels were evaluated using the Visual Analog Scale (VAS) at postoperative 0, 30, 60, 90, and 120 minutes, and at 6, 12, and 24 hours.

This study aims to investigate whether SHPB provides more effective visceral analgesia compared to ESPB and whether this leads to reduced opioid requirements and improved patient satisfaction following TLH.

Conditions

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Total Laparoscopic Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

"This study uses a parallel design where participants are randomly assigned to one of three groups: Superior Hypogastric Plexus Block (SHPB), Erector Spinae Plane Block (ESPB), or Control group. Each group receives its respective intervention or no block in the control group. Outcomes are measured postoperatively to compare analgesic efficacy among groups."
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
The study was conducted in a double-blind manner. Participants, care providers performing the block procedures, and outcome assessors were blinded to group assignments.

Study Groups

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Superior Hypogastric Plexus Block (SHPB) Group

SHPB Group: In this group, patients received a superior hypogastric plexus block (SHPB) following total laparoscopic hysterectomy. After uterus removal and vaginal cuff closure, and before trocar removal, the injection site was identified laparoscopically. The block was performed in all patients by a single surgeon experienced in SHPB.

Group Type ACTIVE_COMPARATOR

Superior Hypogastric Plexus Block (SHPB)

Intervention Type PROCEDURE

Laparoscopic superior hypogastric plexus block with bupivacaine and lidocaine injection near sacral promontory.

Erector Spinae Plane Block Group

ESPB Group: Patients in this group received erector spinae plane block (ESPB) during anesthesia maintenance after surgery. Patients were positioned in the lateral decubitus position. At the T10 level, the ultrasound probe was placed in the midline to identify spinous processes, then moved 2-3 cm laterally to visualize the transverse process, trapezius, and erector spinae muscles. The same procedure was performed on the opposite side. All blocks were performed by a single anesthesiologist experienced in ESPB.

Group Type ACTIVE_COMPARATOR

Erector Spinae Plane Block (ESPB)

Intervention Type PROCEDURE

Erector spinae plane block with ultrasound-guided injection of bupivacaine and lidocaine at T10 level.

Control Group

Control Group: Patients in this group did not receive any block and were managed with standard postoperative care only. This group served as the comparison group to evaluate the effects of the block interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Superior Hypogastric Plexus Block (SHPB)

Laparoscopic superior hypogastric plexus block with bupivacaine and lidocaine injection near sacral promontory.

Intervention Type PROCEDURE

Erector Spinae Plane Block (ESPB)

Erector spinae plane block with ultrasound-guided injection of bupivacaine and lidocaine at T10 level.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female patients aged between 18 and 65 years
* Scheduled for elective total laparoscopic hysterectomy (TLH)
* Classified as American Society of Anesthesiologists (ASA) physical status I or II
* Able to provide written informed consent in accordance with the Declaration of Helsinki

Exclusion Criteria

* Refusal to participate or inability to provide informed consent
* Body mass index (BMI) ≥ 35 kg/m²
* Inability to cooperate or follow instructions
* Presence of spinal or paravertebral deformity
* Known coagulopathy or use of anticoagulant therapy
* Known hypersensitivity or allergy to local anesthetic drugs used in the study
* Requirement for postoperative intensive care
* History of chronic opioid use (longer than four weeks prior to surgery)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr. Lutfi Kirdar Kartal Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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MACİD ORDU

Assistant Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Macid Ordu, MD

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Locations

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Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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DrLutfiKirdarTRH-MO-01

Identifier Type: -

Identifier Source: org_study_id

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