An interventional study of Ultrasound guided sacral erector spinae plane block (SESPB) and Saddle block. in Hemorrhoids, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
Study interventions:
The patients will be randomized into two equal groups, Group A and Group B.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
The surgical procedure will be performed by an experienced surgeon.
The outcome:
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 0, 2, 4, 6, 12, and 24 hours after the procedure. The secondary outcomes will include the cumulative doses of tramadol (50 mg intramuscular) to be repeated every 8 hours in case NRS score is more than four, the number of patients requiring rescue medication in the postoperative period.
Study interventions:
The patients will be randomized into two equal groups using a computer-generated random numbers table, named Group A and Group B. An independent data manager, utilizing computer generated software, will be responsible for the randomization process. Patients will be assigned to the groups through sequentially numbered, sealed, opaque envelopes containing the computer-generated random numbers, which will be accessible only to the anesthesiologist performing the block. The subjects will be randomly allocated to one of the two groups.
Group A: Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Group B: Patients will receive Saddle block.
Preoperatively, history taking, clinical examination and routine laboratory investigation will be performed, patients will be instructed to fast for 6 hours for solids and 2 hours for clear fluids. Upon arrival in the operation room, intravenous access will be established, and an acetated ringer's solution will be infused at a rate of 10ml/kg. ECG, noninvasive blood pressure and arterial oxygen saturation will be routinely monitored. The Numerical Rating Scale (NRS) will be used to assess pain intensity, and all study participants will be trained preoperatively to use the NRS pain score system.
In the operating room, a 20 G peripheral intravenous (IV) cannula will be inserted. Baseline parameters including a five-lead electrocardiogram (ECG), non-invasive blood pressure and peripheral oxygen saturation will be recorded. Intravenous midazolam at a dose of 0.02 mg/kg will then be administered.
The procedure in both groups will be performed by Dr. Riham Fathy Galal who is an anesthesiology consultant.
In group A, following asepsis protocols, patients will undergo a procedure in which a linear ultrasound probe (10-15 MHz)-Sono site M-turbo ultrasonography will be positioned on the transverse plane, specifically on the fifth spinous process. The probe will then be moved downward to visualize the first and second median sacral crests. Subsequently, the transducer will be placed 3 to 4 cm laterally to the second medial sacral crest to visualize the intermediate sacral crest. In the interfacial plane, 20 mL of local anesthetic solution (consisting of 10 mL of 0.5% bupivacaine, 5 mL of 2% lidocaine, and 5 mL of normal saline) will be injected using a 9-cm 22-gauge spinal needle between the erector spinae muscles and the intermediate sacral crest. The same procedure will be performed on the contralateral side.
In group B, Spinal anesthesia will be uniformly administered to the patient in the sitting position. A 25-gauge spinal needle (KDF, China) will be used to perform the spinal anesthesia at the L3-L4 or L4-L5 interspace. After confirming the presence of cerebrospinal fluid, 2 to 2.5 mL of 0.5% hyperbaric bupivacaine hydrochloride will be injected into the intrathecal space. The patients will then be placed in supine position.
After waiting 5 to 10 minutes to confirm that the spinal block level has reached the T10 dermatome, the patients will be repositioned into the lithotomy position. Oxygen will be administered via the nasal cannula at a rate of 2 L/min. If a decrease in blood pressure of greater than 20% from the baseline value is observed, ephedrine (0.1 mg/kg) will be administered. If the heart rate falls below 50 bpm, atropine (0.5 mg/ kg) will be administered.
An experienced surgeon will perform the surgical procedure. At the end of the operation, each patient will receive a single intravenous dose of paracetamol at 15 mg/kg, along with intravenous diclofenac at 1.5 mg/kg (with a maximum dose of 75 mg). During the postoperative period, all patients will receive intravenous paracetamol every 8 hours at a dose of 15 mg/kg, and intravenous diclofenac every 12 hours at a dose of 1.5 mg/kg (with a maximum dose of 75 mg). If the Numeric Rating Scale (NRS)score exceeded three, intravenous tramadol at a dose of 1.5 mg/kg will be administered as rescue analgesia.
The outcome:
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 0, 2, 4, 6, 12, and 24 hours after the procedure. The secondary outcomes will include the cumulative doses of tramadol (50 mg intramuscular) to be repeated every 8 hours in case NRS score is more than 4, the number of patients requiring rescue medication in the postoperative period.
238 studies on the registry are indexed under Hemorrhoids; 73 are open to participants now.
This study's planned enrollment of 50 is below the median of 100 across 183 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Ain Shams University is the lead sponsor of 1,950 studies on the registry; 429 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Ultrasound guided sacral erector spinae plane block (SESPB)
Procedure: Saddle block.
Patients will receive an Ultrasound guided sacral erector spinae plane block (SESPB)
Patients will receive a Saddle block.
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
The primary outcome will be assessment of pain intensity using the NRS ranging from 0 (no pain) to 10 (worst pain) at 12 hours after the procedure.
Time frame: Twenty Four hours after the procedure
Plan to share: No
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