Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair
Ultrasound-Guided Ilioinguinal-Iliohypogastric Nerve Block Following Spinal Anesthesia Comparing Dexmedetomidine Versus Nalbuphine as Adjuvants to Bupivacaine in Unilateral Inguinal Hernia Repair: A Prospective, Randomized, Double-Blind Controlled Study
This study evaluates and compares the pain-relieving efficacy and safety of adding either dexmedetomidine or nalbuphine to bupivacaine in an ultrasound-guided ilioinguinal-iliohypogastric nerve block for patients undergoing elective unilateral inguinal hernia repair under spinal anesthesia.
While spinal anesthesia provides effective surgical anesthesia, postoperative pain often increases as the block recedes. Supplementing spinal anesthesia with an ultrasound-guided peripheral nerve block targeting the ilioinguinal and iliohypogastric nerves provides localized pain relief. Adding adjuvant medications to the local anesthetic may extend the duration of pain control and reduce systemic analgesic requirements.
Participants are randomly allocated to one of three groups:
- Control Group: Receives bupivacaine with normal saline.
- Nalbuphine Group: Receives bupivacaine combined with nalbuphine.
- Dexmedetomidine Group: Receives bupivacaine combined with dexmedetomidine.
The primary objective is to assess the duration of analgesia by measuring the time from the regression of spinal sensory anesthesia until the first request for rescue pain medication. Secondary objectives include evaluating total 24-hour pain medication consumption, postoperative pain scores, vital signs, sedation scores, patient satisfaction, and side effects.
연구 개요
연구 유형
등록 (추정된)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age 18 to 65 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective unilateral primary inguinal hernia repair under spinal anesthesia supplemented with ilioinguinal-iliohypogastric nerve block
- Body weight between 45 and 100 kg and body mass index (BMI) <= 35 kg/m^2
- Ability to understand the study protocol, comply with study requirements, and communicate pain intensity using the Visual Analog Scale (VAS)
Exclusion Criteria:
- Known allergy or hypersensitivity to amide-type local anesthetics, dexmedetomidine, or nalbuphine
- Contraindications to spinal anesthesia (e.g., severe hypovolemia, elevated intracranial pressure, active infection at the lumbar puncture site, severe spinal deformity)
- History of neurological disorders (e.g., peripheral neuropathy, myopathy, seizure disorders, or cognitive impairment)
- Coagulopathy, concurrent anticoagulant therapy, or local infection at the block site contraindicating regional anesthesia
- Severe hepatic, renal, or cardiovascular disease (e.g., heart block, uncontrolled hypertension, ischemic heart disease, severe valvular disease, chronic renal failure, or liver cirrhosis)
- History of opioid or substance abuse
- Emergency surgical procedures
- Procedures expected to exceed 3 hours or requiring conversion to general anesthesia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Group C: Bupivacaine Control
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and 2 mL sterile normal saline (final bupivacaine concentration 0.4%). |
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with 2 mL sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). |
|
실험적: Group N: Nalbuphine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and nalbuphine 10 mg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). |
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with 2 mL sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with nalbuphine 10 mg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). |
|
실험적: Group D: Dexmedetomidine Adjuvant
Patients undergo ultrasound-guided ilioinguinal-iliohypogastric nerve block immediately following spinal anesthesia with a total injectate volume of 10 mL consisting of 8 mL 0.5% bupivacaine (40 mg) and dexmedetomidine 1 µg/kg diluted with sterile normal saline to 10 mL (final bupivacaine concentration 0.4%). |
Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with 2 mL sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). Single-injection ultrasound-guided ilioinguinal-iliohypogastric (IIIH) nerve block administered immediately after spinal anesthesia. The injectate consists of 8 mL 0.5% bupivacaine (40 mg) combined with dexmedetomidine 1 µg/kg, diluted with sterile 0.9% normal saline to achieve a total volume of 10 mL (final bupivacaine concentration 0.4%). |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to First Rescue Analgesia
기간: Up to 24 hours postoperatively
|
Time in minutes from the documented regression of spinal sensory block to the T12 dermatome until the patient's first request for rescue analgesia, administered when the Visual Analog Scale (VAS) pain score is 4 or greater (scale of 0 = no pain to 10 = worst imaginable pain). |
Up to 24 hours postoperatively
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 통증
- 신경학적 징후
- 수술 후 합병증
- 병리학적 과정
- 병리학적 상태, 해부학적
- 헤르니아
- 탈장, 복부
- 병리학적 상태, 징후 및 증상
- 징후 및 증상
- 통증, 수술 후
- 탈장, 서혜부
- 유기 화학 물질
- 이종 사이 클릭 화합물, 1- 링
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 융합 링
- Azoles
- 알칼로이드
- 다 환식 방향족 탄화수소
- 다 환식 화합물
- 이미 다졸
- Anilides
- 아미드
- 아닐린 화합물
- 아민
- 이종 사이 클릭 화합물, 4 개 이상의 고리
- 모르핀
- 아편 알칼로이드
- 이종 사이 클릭 화합물, 브리지 링
- Phenanthrenes
- 부피바카인
- 덱스메데토미딘
- 날부핀
기타 연구 ID 번호
- Dex vs Nalbuphine: Nerve Block
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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