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NCT Number: NCT07078643

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

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.

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Key information

Conditions

Total Laparoscopic Hysterectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, 34862, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Superior Hypogastric Plexus Block (SHPB)

Procedure

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

Erector spinae plane block (ESPB)

Procedure

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

Primary outcomes

  1. Total Tramadol Consumption

    Time frame: Postoperative 0-24 hours

    The total amount of tramadol administered via a patient-controlled analgesia (PCA) device within the first 24 hours after total laparoscopic hysterectomy. This measurement is used to compare the postoperative analgesic efficacy of superior hypogastric plexus block (SHPB) and erector spinae plane block (ESPB) with the control group receiving no block. Tramadol consumption is recorded in milligrams (mg) and extracted directly from PCA device logs.

Secondary outcomes

  1. Postoperative Pain Intensity (VAS Scores)

    Time frame: Postoperative 0-24 hours

    Pain levels will be measured using the Visual Analog Scale (VAS), a 10 cm horizontal line labeled "no pain" at 0 cm and "worst imaginable pain" at 10 cm. Patients will indicate their pain intensity at postoperative time points (e.g., 1h, 6h, 12h, 24h). The score is determined by measuring the distance in centimeters from the "no pain" anchor to the patient's mark. Higher scores indicate greater pain intensity.

  2. Time to First Rescue Analgesia

    Time frame: Postoperative 0-24 hours

    Duration from the end of surgery to the time the patient first requests additional analgesia beyond the standard postoperative regimen.

  3. Incidence of Postoperative Nausea and Vomiting (PONV)

    Time frame: Postoperative 0-24 hours

    The proportion of patients experiencing nausea and/or vomiting within the first 24 hours after surgery.

Sponsors and collaborators

Lead sponsor

Dr. Lutfi Kirdar Kartal Training and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Effects of Superior Hypogastric Plexus Block and Erector Spinae Plane Block on Postoperative Analgesia in Total Laparoscopic Hysterectomy Surgery

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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