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

NCT07078643 | Completed

• 1 other identifier: DrLutfiKirdarTRH-MO-01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Laparoscopic Hysterectomy

Keywords

Postoperative Pain; Erector Spinae Plane Block; Superior Hypogastric Plexus Block

Outcome Measures

Primary Outcomes (1)

• Total Tramadol Consumption

  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.

  Postoperative 0-24 hours

Secondary Outcomes (3)

• Postoperative Pain Intensity (VAS Scores)

  Postoperative 0-24 hours

• Time to First Rescue Analgesia

  Postoperative 0-24 hours

• Incidence of Postoperative Nausea and Vomiting (PONV)

  Postoperative 0-24 hours

Study Arms (3)

Superior Hypogastric Plexus Block (SHPB) Group

ACTIVE COMPARATOR

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.

Procedure: Superior Hypogastric Plexus Block (SHPB)

Erector Spinae Plane Block Group

ACTIVE COMPARATOR

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.

Procedure: Erector Spinae Plane Block (ESPB)

Control Group

NO INTERVENTION

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.

Interventions

Superior Hypogastric Plexus Block (SHPB) PROCEDURE

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

Superior Hypogastric Plexus Block (SHPB) Group

Erector Spinae Plane Block (ESPB) PROCEDURE

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

Erector Spinae Plane Block Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Dr. Lutfi Kirdar Kartal Training and Research Hospital: lead

Study Sites (1)

Kartal Dr. Lütfi Kırdar Training and Research Hospital

Istanbul, 34862, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Macid Ordu, MD

  Kartal Dr. Lütfi Kırdar Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The study was conducted in a double-blind manner. Participants, care providers performing the block procedures, and outcome assessors were blinded to group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Doctor

Model Details: "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."

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: March 1, 2022
• Primary Completion: March 23, 2023
• Study Completion: March 31, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)