- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07800624
Does the Transversus Abdominis Plane(TAP) Block Effectively Manage Pain After Laparoscopic Cholecystectomy?
Does the Transversus Abdominis Plane(TAP) Block Effectively Manage Pain After Laparoscopic Cholecystectomy?. A Randomised Controlled Trial
The study is about managing pain after laparoscopic gallbladder surgery. Pain after surgery is very common and can affect recovery, delay normal activities, and increase the length of hospital stay. Poorly controlled pain can also increase the risk of developing long-term pain.
Good pain control can make patients more comfortable, reduce the need for opioid painkillers, shorten hospital stay, and improve patient satisfaction.
Laparoscopic cholecystectomy is a common surgery for gallstones. Although it is done through small cuts, patients can still experience significant pain after the operation. This pain can come from the surgical wounds, the abdominal organs, and pain felt in other areas.
A TAP block is a type of regional anesthesia that numbs the nerves supplying the abdominal wall. Previous studies have shown that TAP blocks may help reduce pain after surgery. However, there is limited research about its effectiveness in Pakistan and similar settings.
Therefore, this study will compare patients who undergo laparoscopic cholecystectomy with a TAP block to those who undergo the surgery without a TAP block. The study will assess their pain levels, how much pain medication they need, and how long they stay in the hospital.
The main aim is to determine whether using a TAP block can provide better pain control, reduce the need for painkillers, and shorten hospital stay after laparoscopic gallbladder surgery.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This study focuses on the management of pain after laparoscopic cholecystectomy, which is a common surgery performed to remove the gallbladder, usually because of symptomatic gallstones. Although laparoscopic surgery is less invasive than open surgery, patients can still experience significant pain after the procedure. This pain can affect their comfort, recovery, ability to move normally, and the time they need to remain in the hospital.
Postoperative pain is an important problem because poorly controlled acute pain can have both short-term and long-term effects. It may delay recovery, increase the need for painkillers, particularly opioids, and prolong hospital admission. In some patients, inadequately treated acute pain may also contribute to the development of chronic pain. Therefore, effective pain management is an important part of postoperative care.
Laparoscopic cholecystectomy is associated with different types of pain. The pain may come from the surgical incision sites, from the internal abdominal organs, or may be felt in another area of the body as referred pain. Because of these different sources, several methods have been used to control pain after surgery. These include conventional painkillers and different regional anesthesia techniques.
One of these techniques is the Transversus Abdominis Plane block, commonly called a TAP block. In this procedure, local anesthetic is injected into the plane between the abdominal muscles. The aim is to block the nerves that carry pain sensation from the abdominal wall. By reducing pain transmission, the TAP block may decrease the amount of pain experienced by the patient after surgery.
Previous studies have reported that TAP blocks can provide better postoperative pain control and may reduce the need for analgesic medications. However, most of the available evidence comes from studies conducted outside Pakistan. There is relatively limited local evidence about how effective and safe TAP blocks are in Pakistani patients undergoing laparoscopic cholecystectomy. Differences in patient characteristics, surgical techniques, anesthesia practices, and pain management protocols between countries make local research important.
This study is therefore designed to compare patients undergoing laparoscopic cholecystectomy with a TAP block to patients undergoing the same surgery without a TAP block. The researchers will assess whether the TAP block provides better postoperative pain control and reduces the need for additional pain medication.
The study will mainly assess three outcomes. The first is the patient's postoperative pain score, which will show whether patients receiving a TAP block experience less pain. The second is the amount of analgesic medication required after surgery, which will help determine whether the TAP block reduces the need for additional painkillers. The third is the length of hospital stay, which will show whether better pain control allows patients to recover and be discharged earlier.
Overall, the purpose of this study is to determine whether adding a TAP block to laparoscopic cholecystectomy can improve postoperative recovery. If the TAP block is found to significantly reduce pain, decrease analgesic requirements, and shorten hospital stay, it could support the use of TAP blocks as part of routine pain management for patients undergoing laparoscopic cholecystectomy in the local hospital setting.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Zarreen Raza, MBBS, FCPS
- Telefonnummer: +92 3310324008
- E-post: zarreen.raza@jsmu.edu.pk
Studiesteder
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Sindh
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Karachi, Sindh, Pakistan, 75500
- Jinnah postgraduate medical university
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients diagnosed with symptomatic cholelithiasis and advised to undergo laparoscopic cholecystectomy.
- Both Genders
- Age more than 10 years and not above 60 years.
Exclusion Criteria:
- Patients with contraindications for surgery.
- Patients below the age of 10 years or above 60 years.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Laparoscopic cholecystectomy with TAP Block
Patients in this group will undergo laparoscopic cholecystectomy with a Transversus Abdominis Plane (TAP) block.
The TAP block will be given as a regional anesthesia technique to reduce postoperative abdominal pain.
Their postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 0, 6, 12, 24, and 48 hours after surgery.
Their analgesic requirements and length of hospital stay will also be recorded.
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The intervention will consist of a Transversus Abdominis Plane (TAP) block performed in patients undergoing laparoscopic cholecystectomy.
The TAP block will involve the injection of a local anesthetic into the plane between the abdominal muscles to block sensory nerves supplying the abdominal wall.
It will be used to reduce postoperative pain and decrease the need for additional analgesic medication.
Its effectiveness will be assessed by comparing postoperative pain scores, analgesic requirements, and length of hospital stay with patients who do not receive a TAP block.
Andre navn:
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Ingen inngripen: Laparoscopic cholecystectomy without TAP Block
Patients in this group will undergo laparoscopic cholecystectomy without receiving a Transversus Abdominis Plane (TAP) block.
They will receive the usual postoperative pain management provided as part of routine care.
Their postoperative pain will be assessed using the Visual Analogue Scale (VAS) at 0, 6, 12, 24, and 48 hours after surgery.
Their analgesic requirements and length of hospital stay will also be recorded.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative pain score
Tidsramme: At 0 (recovery room), 6, 12, 24, and 48 hours after surgery.
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Pain will be measured using the Visual Analogue Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater postoperative pain (worse outcome).
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At 0 (recovery room), 6, 12, 24, and 48 hours after surgery.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Length of hospital stay
Tidsramme: From the time of completion of surgery until hospital discharge, assessed continuously during the postoperative period up to 7 days after surgery or until discharge, whichever occurs first.
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The duration of hospitalization after laparoscopic cholecystectomy will be measured and compared between patients who receive a TAP block and those who do not.
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From the time of completion of surgery until hospital discharge, assessed continuously during the postoperative period up to 7 days after surgery or until discharge, whichever occurs first.
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Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wang W, Wang L, Gao Y. A Meta-Analysis of Randomized Controlled Trials Concerning the Efficacy of Transversus Abdominis Plane Block for Pain Control After Laparoscopic Cholecystectomy. Front Surg. 2021 Aug 4;8:700318. doi: 10.3389/fsurg.2021.700318. eCollection 2021.
- Zako J, Kevorkov A, Jeffries SD, Ramirez-Garcia Luna JL, Daccache N, Song K, Harutyunyan R, Ritchie C, Cafferty O, Laferriere-Langlois P, Hemmerling TM. Transversus abdominis plane block for postoperative pain management and opioid sparing: a systematic review and meta-analysis of randomised controlled trials. Br J Anaesth. 2026 Jan;136(1):266-282. doi: 10.1016/j.bja.2025.10.033. Epub 2025 Dec 2.
- Atakan Ozkan, Nihat Gulaydin, Bahriye Kilic, Mert Mahsuni Sevinc. Is the application of subcostal transversus abdominis plane block effective for pain control in classical four-port laparoscopic aroscopic cholecystectomy?.Signa Vitae,2024,20(7):69-75 DOI:10.22514/sv.2024.076
- Osit LM, Gammad JJ, Flores OC (2021) The Efficacy of Ultrasound-Guided Bilateral Transversus Abdominal Plane (TAP) Block in Decreasing the Pain After Laparoscopic aroscopic Cholecystectomy : A Randomized Clinical Trial. J Med Res Surg 2(5): pp. 1-6. doi: 10.52916/jmrs214058
- Park S, Park JH, Park S, Jang JN, Kim C, Choi YS. Ultrasound-guided subcostal approach of transversus abdominis plane block compared with wound infiltration for postoperative analgesia following laparoscopic cholecystectomy: A systematic review and meta-analysis. Medicine (Baltimore). 2024 May 3;103(18):e38044. doi: 10.1097/MD.0000000000038044.
- Abraham S, Rivero HG, Erlikh IV, Griffith LF, Kondamudi VK. Surgical and nonsurgical management of gallstones. Am Fam Physician. 2014 May 15;89(10):795-802.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NO.F.2-81/2026-GENL/49/JPMC
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