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

R

Republic of Turkey Ministry of Health

Status

Completed

Conditions

Total Laparoscopic Hysterectomy

Treatments

Procedure: Erector Spinae Plane Block (ESPB)
Procedure: Superior Hypogastric Plexus Block (SHPB)

Study type

Interventional

Funder types

Other

Identifiers

NCT07078643
DrLutfiKirdarTRH-MO-01

Details and patient eligibility

About

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.

Full description

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.

Enrollment

90 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 3 patient groups

Superior Hypogastric Plexus Block (SHPB) Group
Active Comparator group
Description:
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.
Treatment:
Procedure: Superior Hypogastric Plexus Block (SHPB)
Erector Spinae Plane Block Group
Active Comparator group
Description:
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.
Treatment:
Procedure: Erector Spinae Plane Block (ESPB)
Control Group
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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