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Transversus Abdominis Plane Block in Iliac Crest harvest-is it Beneficial?

2016년 12월 20일 업데이트: Dr. Vigil Peter, Jubilee Mission Medical College and Research Institute

Transversus Abdominis Plane Block Supplementation During Iliac Crest Bone Graft Harvest - Its Influence on Postoperative Parameters

The purpose of this study is to determine whether a supplemental Transversus Abdominis Plane block administered intraoperatively improves the postoperative parameters in patients undergoing Alveolar bone grafting with iliac crest harvest. It also aims to find out if there is a decrease in the incidence of chronic pain or numbness at the harvest site.

연구 개요

상세 설명

This study is a prospective, randomised, parallel group, single - centre trial evaluating the postoperative parameters in patients receiving supplemental Transversus Abdominis Plane block for anterior iliac crest harvest. It was conducted in 143 patients undergoing Alveolar bone grafting with iliac crest bone graft.

Methodology:

Informed consent and approval of local ethics and research committee in Jubilee Mission Medical College and Research Institute, Thrissur, India was obtained prior to initiation of the study. A pilot study was done to determine the efficacy of the additional TAP block. The results showed that the intervention improved patient analgesia and reduced the requirement for rescue analgesics. A minimum sample size of 65 patients was calculated for each group to obtain a power of 80% and confidence interval of 95%. 143 patients aged between 7 and 22 years posted for Alveolar bone grafting with anterior iliac crest harvest were assessed in the study. Only those undergoing Alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate were considered for the study. The patients who had difficulty in mentation and communication,bleeding disorders, hepatic problems, infection of the abdominal wall, renal dysfunction as well as allergy to the local anaesthetic were excluded from the study. Patients undergoing revision surgeries were also excluded from the study. All the candidates were randomly alloted to either of the two groups, using a computer - generated number.

All the patients were premedicated with Midazolam 0.15mg kg-1 and Glycopyrolate 0.01mg kg-1 Anaesthesia was induced with Propofol 2 mg kg -1 and Fentanyl 2 mcg kg-1 .Vecuronium 0.1 mg kg-1 was given to facilitate orotracheal intubation with a cuffed tube.Anaesthesia was maintained with oxygen, nitrous oxide and sevoflurane. Prior to incision, all the patients were given wound infiltration with 0.75 ml kg-1 of 0.2% Ropivacaine at the graft harvest site. Those in group A received an additional ultrasound guided Transversus Abdominis Plane block with a similar volume and concentration of Ropivacaine.

At the end of the surgical procedure, the patients were extubated awake, after giving I / V Neostigmine 0.05 mg kg-1. Just prior to extubation, I/V Tramadol 0.5 mg kg-1 was given for the pain in the postoperative period. In the recovery room, the pain and emergence delirium were assessed by an independent observer every ten minutes during the first postoperative hour.These were evaluated using the FLACC Behavioural Pain Assessment Scale and WATCHA Scale respectively. They were subsequently shifted to the postoperative ward.

The next time point of assessment was 24 hours post - surgery, when the patient's pain and ambulatory status were evaluated. The pain was ranked using the five - point verbal ranking score. It was ranked as no pain, light pain, moderate pain, severe pain and intolerable pain, with a score of 0,1,2,3 and 4 respectively. The total number of rescue analgesics demanded by the patient on the first postoperative day was noted.Ambulatory status was graded using one - day Cumulated Ambulatory Score.

The patients were followed up and questioned at six weeks and twelve weeks post operatively for the presence of chronic pain, numbness or wound healing problems at the harvest site.

연구 유형

중재적

등록 (실제)

143

단계

  • 해당 없음

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

4년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Must undergo alveolar bone grafting as a part of the reconstructive procedure for cleft lip and palate

Exclusion Criteria:

  • Revision procedure
  • History of difficulty in mentation and communication
  • Bleeding disorders, hepatic problems or renal dysfunction
  • Allergy to local anaesthetic
  • Presence of infection of anterior abdominal wall

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Local Infiltration with TAP block
Ultrasound guided Transversus Abdominis Plane block is administered intraoperatively using 0.2% Ropivacaine.
Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
실험적: Local Infiltration only
Local Infiltration with 0.2% Ropivacaine.
Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Mean pain scores
기간: First hour after extubation
Mean pain scores were assessed using the FLACC Behavioural Pain Assessment Scale,
First hour after extubation
Emergence delirium
기간: First hour after extubation
Emergence delirium was assessed using WATCHA Scale during the first hour after extubation
First hour after extubation
Pain scores
기간: 24 hours after surgery
Pain scores using the five - point verbal ranking score 24 hours after surgery
24 hours after surgery
Ambulatory status
기간: 24 hours after surgery
Ambulatory status was assessed using one - day Cumulated Ambulatory Score 24 hours after surgery
24 hours after surgery

2차 결과 측정

결과 측정
측정값 설명
기간
Infection and delayed healing at the graft harvest site
기간: 6 weeks after surgery
All patients were interviewed for the presence of infection or delayed healing at the graft harvest site 6 weeks after surgery.
6 weeks after surgery
Chronic pain, numbness or discomfort at graft harvest site
기간: 12 weeks after the surgery
All the patients were reviewed 12 weeks after surgery for the presence of chronic pain, numbness or discomfort at iliac crest harvest
12 weeks after the surgery

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Vigil Peter, MD, Jubilee Mission Medical College and Research Institute

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2016년 4월 1일

기본 완료 (실제)

2016년 8월 1일

연구 완료 (실제)

2016년 11월 1일

연구 등록 날짜

최초 제출

2016년 12월 15일

QC 기준을 충족하는 최초 제출

2016년 12월 16일

처음 게시됨 (추정)

2016년 12월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2016년 12월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2016년 12월 20일

마지막으로 확인됨

2016년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • 07/16/IEC/JMMC&RI

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

통증, 수술 후에 대한 임상 시험

local infiltration and TAP block에 대한 임상 시험

구독하다