Intrathecal Morphine and Transversalis Fascia Plane Block for Analgesia After Open Inguinal Hernia Repair

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAtatürk Chest Diseases and Chest Surgery Training and Research Hospital

About this trial

Inguinal hernia is a common surgical condition, and open inguinal hernia repair may be associated with significant postoperative pain. Inadequate pain control can delay early mobilization, reduce patient comfort, and increase the need for opioid analgesics. Therefore, effective postoperative pain management is an important component of perioperative care.

Several analgesic strategies can be used after open inguinal hernia repair, including systemic multimodal analgesia, neuraxial opioids, and regional anesthesia techniques. Intrathecal morphine can provide prolonged postoperative analgesia but may be associated with opioid-related adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. Ultrasound-guided transversalis fascia plane block is a regional anesthesia technique designed to provide analgesia to the inguinal region while potentially reducing systemic opioid requirements.

The aim of this prospective, randomized, assessor-blinded, controlled trial is to compare the postoperative analgesic efficacy of intrathecal morphine, transversalis fascia plane block, and spinal anesthesia alone in adult patients undergoing elective open unilateral inguinal hernia repair.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 80 years

American Society of Anesthesiologists physical status I-II-III

Body mass index between 18 and 30 kg/m²

Patients undergoing elective open inguinal hernia repair

Disqualifiers

Patient refusing the procedure

History of chronic analgesic or opioid therapy

History of local anesthetic and morphine allergy

Infection in the intervention area

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine Group

    Procedure/Surgery

    Spinal anesthesia will be performed using 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, prepared to a total intrathecal volume of 3 mL. No additional peripheral regional block will be performed in this group. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.

  • Transversalis Fascia Plane Block Group

    Procedure/Surgery

    Spinal anesthesia will be performed with 15 mg of 0.5% hyperbaric bupivacaine (3 mL). At the completion of surgery, an ultrasound-guided unilateral transversalis fascia plane block will be performed on the surgical side. A 22-gauge, 80-100 mm block needle will be advanced using an in-plane technique to the transversalis fascial plane, and 30 mL of 0.25% bupivacaine will be injected after negative aspiration. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.

  • Control Group

    Procedure/Surgery

    Spinal anesthesia will be performed using 12.5 mg of 0.5% hyperbaric bupivacaine combined with 0.1 mg (100 mcg) of intrathecal morphine, prepared to a total intrathecal volume of 3 mL. No additional peripheral regional block will be performed in this group. Participants will subsequently receive the standardized postoperative multimodal analgesia and intravenous patient-controlled analgesia protocol.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Intrathecal MorphineActive comparator 1 intervention
Group B: Transversalis Fascia Plane BlockActive comparator 1 intervention
Group C: Spinal Anesthesia AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Morphine Consumption via Patient-Controlled Analgesia

The total amount of intravenous morphine administered via patient-controlled analgesia during the first 24 postoperative hours will be recorded in milligrams (mg) based on the PCA device records.

Time frame
Up to 24 hours after surgery

Secondary outcomes

1

Pain scores

Pain will be assessed at rest using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.

Time frame
Up to 24 hours after surgery
2

Pain scores

Pain will be assessed while coughing using the visual analog scale on a scale from 0 mm (no pain) to 100 mm (worst pain). Pain assessment will be done at the 1st, 4th, 8th, 12th, and 24th hours after surgery.

Time frame
Up to 24 hours after surgery
3

Total Rescue Tramadol Consumption

The total amount of intravenous tramadol administered as rescue analgesia during the first 24 postoperative hours will be recorded in milligrams (mg). Intravenous tramadol will be administered when the Visual Analog Scale (VAS) pain score is greater than 40 mm.

Time frame
Up to 24 hours after surgery
4

Side effects

Side effects, such as allergy , hypotension, nausea/vomiting, and itching, will be recorded.

Time frame
Up to 24 hours after surgery

Other outcomes

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