An interventional study of Ultrasound-Guided Pudendal Nerve Block and Landmark-Guided Pudendal Nerve Block in Hemorrhoids, Postoperative Pain and Pudendal Nerve Block, sponsored by Konya City Hospital. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Konya City Hospital · Not applicable, Interventional, and Treatment
Hemorrhoid surgery is often followed by significant pain during the first few days after the operation. Pudendal nerve block is a pain-control technique that can help reduce discomfort after surgery. This study will compare two different methods of performing a pudendal nerve block: an ultrasound-guided method and a conventional landmark-guided method.
Patients undergoing Milligan-Morgan hemorrhoidectomy will be randomly assigned to one of the two techniques. The study will evaluate postoperative pain levels, pain medication use, treatment-related complications, and patient satisfaction.
The study hypothesis is that the ultrasound-guided technique may provide better pain relief and reduce the need for additional pain medication compared with the landmark-guided technique.
Hemorrhoidal disease is one of the most common benign anorectal disorders worldwide. Milligan-Morgan hemorrhoidectomy remains one of the most effective surgical treatments for advanced hemorrhoidal disease; however, postoperative pain continues to be a major limitation of the procedure. Pain after hemorrhoidectomy may delay mobilization, increase analgesic requirements, prolong recovery, and negatively affect patient satisfaction.
Several pharmacological and regional analgesic techniques have been investigated to improve postoperative pain management following hemorrhoidectomy. Among these techniques, pudendal nerve block has gained increasing attention because it provides targeted analgesia to the anal canal and perianal region while minimizing systemic adverse effects associated with opioid-based pain management. Previous randomized controlled trials and meta-analyses have demonstrated that pudendal nerve block can reduce postoperative pain intensity, decrease analgesic consumption, and improve postoperative recovery after anorectal surgery.
Traditionally, pudendal nerve block has been performed using anatomical landmarks identified by digital palpation of the ischial spine. Although this technique is widely used and does not require additional equipment, the success of the block depends largely on operator experience and anatomical variation. Inaccurate needle placement may reduce block efficacy and increase the risk of technical failure.
The introduction of ultrasound-guided regional anesthesia has enabled direct visualization of anatomical structures, including the internal pudendal vessels and surrounding soft tissues. Ultrasound guidance may improve needle placement accuracy, facilitate local anesthetic spread around the target nerve, and potentially reduce procedure-related complications. Several studies have reported favorable outcomes with ultrasound-guided pudendal nerve block; however, most available evidence compares pudendal nerve block with other anesthetic or analgesic techniques rather than directly comparing different pudendal block approaches.
Currently, there is limited prospective randomized evidence comparing ultrasound-guided and conventional landmark-guided pudendal nerve block techniques in patients undergoing hemorrhoidectomy. Therefore, the relative clinical advantages of ultrasound guidance in this setting remain uncertain.
This single-center, prospective, randomized, double-blind clinical trial has been designed to compare ultrasound-guided and landmark-guided bilateral pudendal nerve block techniques performed after Milligan-Morgan hemorrhoidectomy. The study seeks to determine whether ultrasound guidance provides clinically meaningful benefits in postoperative pain management and recovery when compared with the conventional landmark-guided approach. The results may contribute to the optimization of perioperative pain management strategies and help guide evidence-based selection of pudendal nerve block techniques in routine colorectal surgical practice.
226 studies on the registry are indexed under Hemorrhoids; 66 are open to participants now.
This study's planned enrollment of 80 is below the median of 97 across 173 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Konya City Hospital is the lead sponsor of 78 studies on the registry; 21 are open to participants now.
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Exclusion Criteria:
Participants undergoing Milligan-Morgan hemorrhoidectomy will receive bilateral ultrasound-guided pudendal nerve block after completion of surgery under spinal anesthesia. The block will be performed by an anesthesiologist using ultrasound guidance and a standardized local anesthetic mixture.
Procedure: Ultrasound-Guided Pudendal Nerve Block
Participants undergoing Milligan-Morgan hemorrhoidectomy will receive bilateral landmark-guided pudendal nerve block after completion of surgery under spinal anesthesia. The block will be performed using digital palpation of the ischial spine and the same standardized local anesthetic mixture.
Procedure: Landmark-Guided Pudendal Nerve Block
Bilateral pudendal nerve block performed under ultrasound guidance using a standardized mixture of 1% lidocaine and 0.25% bupivacaine following Milligan-Morgan hemorrhoidectomy.
Bilateral pudendal nerve block performed using anatomical landmarks identified by digital palpation of the ischial spine with the same standardized mixture of 1% lidocaine and 0.25% bupivacaine following Milligan-Morgan hemorrhoidectomy.
Postoperative Pain Intensity at 24 Hours
Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 24 hours after surgery
Postoperative Pain Intensity at 6, 12, and 48 Hours
Postoperative pain intensity will be assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 6, 12, and 48 hours after surgery
Total Postoperative Analgesic Consumption
Total rescue analgesic consumption during the first 48 hours after surgery will be recorded and compared between study groups.
Time frame: Within 48 hours after surgery
Incidence of Early Postoperative Complications
The incidence of urinary retention and postoperative nausea and vomiting occurring during the first 48 hours after surgery will be recorded.
Time frame: Within 48 hours after surgery
Patient Satisfaction
Patient satisfaction with postoperative pain management will be assessed at 48 hours after surgery using a 5-point Likert scale, with higher scores indicating greater satisfaction.
Time frame: 48 hours after surgery
Quality of Postoperative Recovery
Quality of postoperative recovery will be assessed at 48 hours after surgery using the Quality of Recovery-15 (QoR-15) questionnaire. The questionnaire consists of 15 items, with a total score ranging from 0 to 150. Higher scores indicate better postoperative recovery.
Time frame: 48 hours after surgery
Plan to share: No
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Konya City Hospital