Total Laparoscopic Hysterectomy
Conditions
Keywords
Postoperative Pain, Erector Spinae Plane Block, Superior Hypogastric Plexus Block
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.
Detailed 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.
Interventions
PROCEDURESuperior Hypogastric Plexus Block (SHPB)
Laparoscopic superior hypogastric plexus block with bupivacaine and lidocaine injection near sacral promontory.
PROCEDUREErector Spinae Plane Block (ESPB)
Erector spinae plane block with ultrasound-guided injection of bupivacaine and lidocaine at T10 level.
Sponsors
Dr. Lutfi Kirdar Kartal Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
The study was conducted in a double-blind manner. Participants, care providers performing the block procedures, and outcome assessors were blinded to group assignments.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Tramadol Consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity (VAS Scores) | 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. |
| Time to First Rescue Analgesia | Postoperative 0-24 hours | Duration from the end of surgery to the time the patient first requests additional analgesia beyond the standard postoperative regimen. |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Postoperative 0-24 hours | The proportion of patients experiencing nausea and/or vomiting within the first 24 hours after surgery. |
Countries
Turkey (Türkiye)
Outcome results
None listed